Schedule 1—Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024)
[1] Schedule 1, Part 1, entry for Acalabrutinib
omit:
Acalabrutinib | Capsule 100 mg | Oral | Calquence | AP | MP | C12495 C12500 C14788 | | 56 | 5 | | 56 | | |
[2] Schedule 1, Part 1, entry for Aciclovir in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Aciclovir | Tablet 200 mg | Oral | ARX-ACICLOVIR | XT | MP NP | C5942 | | 90 | 5 | | 90 | | |
[3] Schedule 1, Part 1, entry for Alirocumab in each of the forms: Injection 75 mg in 1 mL single use pre-filled pen; and Injection 150 mg in 1 mL single use pre-filled pen
(a) omit from the column headed “Circumstances”: C15106 C15107
(b) insert in numerical order in the column headed “Circumstances”: C15366 C15409
[4] Schedule 1, Part 1, entry for Amlodipine in the form Tablet 5 mg (as besilate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Amlodipine | Tablet 5 mg (as besilate) | Oral | APX-AMLODIPINE | TW | MP NP | | | 30 | 5 | | 30 | | |
Amlodipine | Tablet 5 mg (as besilate) | Oral | APX-AMLODIPINE | TW | MP NP | | P14238 | 60 | 5 | | 30 | | |
[5] Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid
(a) omit:
Amoxicillin with clavulanic acid | Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 50 mL (S19A) | Oral | Amoxicillin and clavulanate potassium for oral suspension, USP 400 mg/57 mg per 5 mL (Aurobindo) | DZ | PDP | C5833 C5894 | P5833 P5894 | 1 | 0 | | 1 | | |
Amoxicillin with clavulanic acid | Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 50 mL (S19A) | Oral | Amoxicillin and clavulanate potassium for oral suspension, USP 400 mg/57 mg per 5 mL (Aurobindo) | DZ | MP NP | C5832 C5893 | P5832 P5893 | 1 | 1 | | 1 | | |
(b) omit:
Amoxicillin with clavulanic acid | Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A) | Oral | Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo - Medsurge) | DZ | MP NP | C5832 C5893 | P5832 P5893 | 10 | 0 | | 20 | | |
Amoxicillin with clavulanic acid | Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A) | Oral | Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo - Medsurge) | DZ | PDP | C5833 C5894 | P5833 P5894 | 10 | 0 | | 20 | | |
Amoxicillin with clavulanic acid | Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A) | Oral | Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo - Medsurge) | DZ | MP NP | C10413 | P10413 | 20 | 0 | | 20 | | |
[6] Schedule 1, Part 1, after entry for Anastrozole in the form Tablet 1 mg [Brand: Arianna 1; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Anifrolumab | Solution concentrate for I.V. infusion 300 mg in 2 mL | Injection | Saphnelo | AP | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 1 | | D(100) |
[7] Schedule 1, Part 1, entry for Aripiprazole in the form Tablet 10 mg
omit:
Aripiprazole | Tablet 10 mg | Oral | Aripic Aripiprazole | LR | MP NP | C4246 | | 30 | 5 | | 30 | | |
[8] Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium)
omit:
Atorvastatin | Tablet 10 mg (as calcium) | Oral | Atorvastatin GH | GQ | MP NP | | | 30 | 5 | | 30 | | |
Atorvastatin | Tablet 10 mg (as calcium) | Oral | Atorvastatin GH | GQ | MP NP | | P14238 | 60 | 5 | | 30 | | |
[9] Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium)
omit:
Atorvastatin | Tablet 40 mg (as calcium) | Oral | Atorvastatin GH | GQ | MP NP | | | 30 | 5 | | 30 | | |
Atorvastatin | Tablet 40 mg (as calcium) | Oral | Atorvastatin GH | GQ | MP NP | | P14238 | 60 | 5 | | 30 | | |
[10] Schedule 1, Part 1, entry for Benzathine benzylpenicillin in the form Powder for injection 1,200,000 units with diluent 5 mL (S19A)
omit:
Benzathine benzylpenicillin | Powder for injection 1,200,000 units with diluent 5 mL (S19A) | Injection | Benzylpenicillin Benzathine (Brancaster Pharma, UK) | OJ | PDP MP NP | | | 10 | 0 | | 1 | | |
[11] Schedule 1, Part 1, entry for Bivalirudin
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Bivalirudin | Powder for I.V. injection 250 mg (as trifluoroacetate) | Injection | BIVALIRUDIN ARX | XT | MP | C4919 | | 1 | 0 | | 1 | | |
[12] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 8 mg in 0.16 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 8 mg in 0.16 mL pre-filled syringe | Injection | Buvidal Weekly | UR | MP NP | C15385 | | 4 | 5 | | 1 | | PB(100) |
[13] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 16 mg in 0.32 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 16 mg in 0.32 mL pre-filled syringe | Injection | Buvidal Weekly | UR | MP NP | C15385 | | 4 | 5 | | 1 | | PB(100) |
[14] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 24 mg in 0.48 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 24 mg in 0.48 mL pre-filled syringe | Injection | Buvidal Weekly | UR | MP NP | C15385 | | 4 | 5 | | 1 | | PB(100) |
[15] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 32 mg in 0.64 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 32 mg in 0.64 mL pre-filled syringe | Injection | Buvidal Weekly | UR | MP NP | C15385 | | 4 | 5 | | 1 | | PB(100) |
[16] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 64 mg in 0.18 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 64 mg in 0.18 mL pre-filled syringe | Injection | Buvidal Monthly | UR | MP NP | C15356 | | 1 | 5 | | 1 | | PB(100) |
[17] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 96 mg in 0.27 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 96 mg in 0.27 mL pre-filled syringe | Injection | Buvidal Monthly | UR | MP NP | C15356 | | 1 | 5 | | 1 | | PB(100) |
[18] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 100 mg in 0.5 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 100 mg in 0.5 mL pre-filled syringe | Injection | Sublocade | IR | MP NP | C15439 | | 1 | 5 | | 1 | | PB(100) |
[19] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 128 mg in 0.36 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 128 mg in 0.36 mL pre-filled syringe | Injection | Buvidal Monthly | UR | MP NP | C15356 | | 1 | 5 | | 1 | | PB(100) |
[20] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 160 mg in 0.45 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 160 mg in 0.45 mL pre-filled syringe | Injection | Buvidal Monthly | UR | MP NP | C15356 | | 1 | 5 | | 1 | | PB(100) |
[21] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 300 mg in 1.5 mL pre-filled syringe
substitute:
Buprenorphine | Injection (modified release) 300 mg in 1.5 mL pre-filled syringe | Injection | Sublocade | IR | MP NP | C15439 | | 1 | 5 | | 1 | | PB(100) |
[22] Schedule 1, Part 1, entry for Buprenorphine in the form Tablet (sublingual) 400 micrograms (as hydrochloride)
substitute:
Buprenorphine | Tablet (sublingual) 400 micrograms (as hydrochloride) | Sublingual | Subutex | IR | MP NP | C15355 | | 28 | 5 | | 7 | | PB(100) |
[23] Schedule 1, Part 1, entry for Buprenorphine in the form Tablet (sublingual) 2 mg (as hydrochloride)
substitute:
Buprenorphine | Tablet (sublingual) 2 mg (as hydrochloride) | Sublingual | Subutex | IR | MP NP | C15355 | | 84 | 5 | | 7 | | PB(100) |
[24] Schedule 1, Part 1, entry for Buprenorphine in the form Tablet (sublingual) 8 mg (as hydrochloride)
substitute:
Buprenorphine | Tablet (sublingual) 8 mg (as hydrochloride) | Sublingual | Subutex | IR | MP NP | C15355 | | 112 | 5 | | 7 | | PB(100) |
[25] Schedule 1, Part 1, entry for Buprenorphine with naloxone
substitute:
Buprenorphine with naloxone | Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride) | Sublingual | Suboxone Film 2/0.5 | IR | MP NP | C15355 | | 84 | 5 | | 28 | | D(100) |
Buprenorphine with naloxone | Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride) | Sublingual | Suboxone Film 8/2 | IR | MP NP | C15355 | | 112 | 5 | | 28 | | D(100) |
[26] Schedule 1, Part 1, entry for Calcium in the form Tablet, chewable, 500 mg (as carbonate)
substitute:
Calcium | Tablet, chewable, 500 mg (as carbonate) | Oral | Cal-500 | PP | MP | C4586 | P4586 | 240 | 1 | | 120 | | |
Calcium | Tablet, chewable, 500 mg (as carbonate) | Oral | Cal-500 | PP | NP | C4586 | | 240 | 1 | | 120 | | |
Calcium | Tablet, chewable, 500 mg (as carbonate) | Oral | Cal-500 | PP | MP | C14228 | P14228 | 480 | 1 | | 120 | | |
[27] Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg
omit:
Candesartan | Tablet containing candesartan cilexetil 4 mg | Oral | NOUMED CANDESARTAN | VO | MP NP | | | 30 | 5 | | 30 | | |
Candesartan | Tablet containing candesartan cilexetil 4 mg | Oral | NOUMED CANDESARTAN | VO | MP NP | | P14238 | 60 | 5 | | 30 | | |
[28] Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg
omit:
Candesartan | Tablet containing candesartan cilexetil 8 mg | Oral | NOUMED CANDESARTAN | VO | MP NP | | | 30 | 5 | | 30 | | |
Candesartan | Tablet containing candesartan cilexetil 8 mg | Oral | NOUMED CANDESARTAN | VO | MP NP | | P14238 | 60 | 5 | | 30 | | |
[29] Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg
omit:
Candesartan | Tablet containing candesartan cilexetil 16 mg | Oral | NOUMED CANDESARTAN | VO | MP NP | | | 30 | 5 | | 30 | | |
Candesartan | Tablet containing candesartan cilexetil 16 mg | Oral | NOUMED CANDESARTAN | VO | MP NP | | P14238 | 60 | 5 | | 30 | | |
[30] Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg
omit:
Candesartan | Tablet containing candesartan cilexetil 32 mg | Oral | NOUMED CANDESARTAN | VO | MP NP | | | 30 | 5 | | 30 | | |
Candesartan | Tablet containing candesartan cilexetil 32 mg | Oral | NOUMED CANDESARTAN | VO | MP NP | | P14238 | 60 | 5 | | 30 | | |
[31] Schedule 1, Part 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)
omit:
Ceftriaxone | Powder for injection 2 g (as sodium) | Injection | Ceftriaxone Alphapharm | AF | MP NP | C5826 C5881 C5890 | | 5 | 0 | | 5 | | |
Ceftriaxone | Powder for injection 2 g (as sodium) | Injection | Ceftriaxone Alphapharm | AF | MP NP | C5826 C5881 C5890 | | 5 | 0 | | 10 | | |
[32] Schedule 1, Part 1, entry for Cetuximab
substitute:
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | Erbitux | SG | MP | C4788 | P4788 | See Note 3 | See Note 3 | | 1 | | D(100) |
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | Erbitux | SG | MP | C4785 C4794 | P4785 P4794 | See Note 3 | See Note 3 | | 1 | | D(100) |
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | Erbitux | SG | MP | C4908 C12045 C12483 | P4908 P12045 P12483 | See Note 3 | See Note 3 | | 1 | | D(100) |
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | Erbitux | SG | MP | C12016 C12470 | P12016 P12470 | See Note 3 | See Note 3 | | 1 | | D(100) |
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | Erbitux | SG | MP | C4912 | P4912 | See Note 3 | See Note 3 | | 1 | | D(100) |
Cetuximab | Solution for I.V. infusion 500 mg in 100 mL | Injection | Erbitux | SG | MP | C4788 | P4788 | See Note 3 | See Note 3 | | 1 | | D(100) |
Cetuximab | Solution for I.V. infusion 500 mg in 100 mL | Injection | Erbitux | SG | MP | C4785 C4794 | P4785 P4794 | See Note 3 | See Note 3 | | 1 | | D(100) |
Cetuximab | Solution for I.V. infusion 500 mg in 100 mL | Injection | Erbitux | SG | MP | C4908 C12045 C12483 | P4908 P12045 P12483 | See Note 3 | See Note 3 | | 1 | | D(100) |
Cetuximab | Solution for I.V. infusion 500 mg in 100 mL | Injection | Erbitux | SG | MP | C12016 C12470 | P12016 P12470 | See Note 3 | See Note 3 | | 1 | | D(100) |
Cetuximab | Solution for I.V. infusion 500 mg in 100 mL | Injection | Erbitux | SG | MP | C4912 | P4912 | See Note 3 | See Note 3 | | 1 | | D(100) |
[33] Schedule 1, Part 1, entry for Clindamycin
omit:
Clindamycin | Capsule 150 mg (as hydrochloride) | Oral | Clindamycin BNM | BZ | PDP | C5487 | P5487 | 24 | 0 | | 24 | | |
Clindamycin | Capsule 150 mg (as hydrochloride) | Oral | Clindamycin BNM | BZ | MP NP MW | C5470 | P5470 | 48 | 1 | | 24 | | |
[34] Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Brand: Androcur]
omit from the column headed “Responsible Person” (all instances): BN substitute (all instances): GH
[35] Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg [Brand: Androcur-100]
omit from the column headed “Responsible Person” (all instances): BN substitute (all instances): GH
[36] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 75 mg (as mesilate)
omit:
Dabigatran etexilate | Capsule 75 mg (as mesilate) | Oral | PHARMACOR DABIGATRAN | CR | MP NP | C4381 | P4381 | 20 | 0 | | 10 | | |
Dabigatran etexilate | Capsule 75 mg (as mesilate) | Oral | PHARMACOR DABIGATRAN | CR | MP NP | C4369 | P4369 | 20 | 1 | | 10 | | |
[37] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 75 mg (as mesilate) [Brand: PHARMACOR DABIGATRAN; Maximum Quantity: 60; Number of Repeats: 0]
omit from the column headed “Purposes”: P4402
[38] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate)
omit:
Dabigatran etexilate | Capsule 110 mg (as mesilate) | Oral | PHARMACOR DABIGATRAN | CR | MP NP | C4381 | P4381 | 20 | 0 | | 10 | | |
Dabigatran etexilate | Capsule 110 mg (as mesilate) | Oral | PHARMACOR DABIGATRAN | CR | MP NP | C4369 | P4369 | 20 | 1 | | 10 | | |
[39] Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 100 mg [Brand: TE-DASATINIB; Maximum Quantity: 30; Number of Repeats: 5]
insert:
Daunorubicin with cytarabine | Powder for I.V. infusion containing daunorubicin 44 mg (as hydrochloride) and cytarabine 100 mg | Injection | Vyxeos | JA | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 1 | | D(100) |
[40] Schedule 1, Part 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”:
Desvenlafaxine | Tablet (modified release) 50 mg | Oral | BTC Desvenlafaxine | BG | MP NP | C5650 | | 28 | 5 | | 28 | | |
[41] Schedule 1, Part 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”:
Desvenlafaxine | Tablet (modified release) 100 mg | Oral | BTC Desvenlafaxine | BG | MP NP | C5650 | | 28 | 5 | | 28 | | |
[42] Schedule 1, Part 1, entry for Deucravacitinib
omit from the column headed “Circumstances”: C15330 substitute: C15406
[43] Schedule 1, Part 1, entry for Dupilumab
substitute:
Dupilumab | Injection 200 mg in 1.14 mL single dose pre-filled syringe | Injection | Dupixent | SW | MP | C11374 C11377 C12497 C12507 | P11374 P11377 P12497 P12507 | 2 | 5 | | 2 | | |
Dupilumab | Injection 200 mg in 1.14 mL single dose pre-filled syringe | Injection | Dupixent | SW | MP | C15348 | See Note 3 | See Note 3 | See Note 3 | | 2 | | C(100) |
Dupilumab | Injection 200 mg in 1.14 mL single dose pre-filled syringe | Injection | Dupixent | SW | MP | C15341 C15433 | See Note 3 | See Note 3 | See Note 3 | | 2 | | C(100) |
Dupilumab | Injection 300 mg in 2 mL single dose pre-filled syringe | Injection | Dupixent | SW | MP | C11374 C11377 C12497 C12507 | P11374 P11377 P12497 P12507 | 2 | 5 | | 2 | | |
Dupilumab | Injection 300 mg in 2 mL single dose pre-filled syringe | Injection | Dupixent | SW | MP | C15348 | See Note 3 | See Note 3 | See Note 3 | | 2 | | C(100) |
Dupilumab | Injection 300 mg in 2 mL single dose pre-filled syringe | Injection | Dupixent | SW | MP | C15424 C15425 | See Note 3 | See Note 3 | See Note 3 | | 2 | | C(100) |
[44] Schedule 1, Part 1, entry for Evolocumab in the form Injection 140 mg in 1 mL single use pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C15079 C15092
(b) insert in numerical order in the column headed “Circumstances”: C15395 C15410
(c) omit from the column headed “Purposes”: P15079 P15092
(d) insert in numerical order in the column headed “Purposes”: P15395 P15410
[45] Schedule 1, Part 1, entry for Evolocumab in the form Injection 140 mg in 1 mL single use pre-filled pen [Maximum Quantity: 3; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C13469
(b) insert in numerical order in the column headed “Circumstances”: C15432
(c) omit from the column headed “Purposes”: P13469
(d) insert in numerical order in the column headed “Purposes”: P15432
[46] Schedule 1, Part 1, entry for Evolocumab in the form Injection 420 mg in 3.5 mL single use pre-filled cartridge
(a) omit from the column headed “Circumstances”: C13469 C15079 C15092
(b) insert in numerical order in the column headed “Circumstances”: C15395 C15410 C15432
[47] Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Fluticasone propionate with salmeterol | Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | SalplusF DPI 250/50 | SZ | MP NP | C15138 | | 1 | 5 | | 1 | | |
[48] Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Fluticasone propionate with salmeterol | Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | SalplusF DPI 500/50 | SZ | MP NP | C10121 C15118 | | 1 | 5 | | 1 | | |
[49] Schedule 1, Part 1, entry for Glimepiride in the form Tablet 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Glimepiride | Tablet 1 mg | Oral | ARX-GLIMEPIRIDE | XT | MP NP | | | 30 | 5 | | 30 | | |
Glimepiride | Tablet 1 mg | Oral | ARX-GLIMEPIRIDE | XT | MP NP | | P14238 | 60 | 5 | | 30 | | |
[50] Schedule 1, Part 1, entry for Glimepiride in the form Tablet 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Glimepiride | Tablet 2 mg | Oral | ARX-GLIMEPIRIDE | XT | MP NP | | | 30 | 5 | | 30 | | |
Glimepiride | Tablet 2 mg | Oral | ARX-GLIMEPIRIDE | XT | MP NP | | P14238 | 60 | 5 | | 30 | | |
[51] Schedule 1, Part 1, entry for Glimepiride in the form Tablet 3 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Glimepiride | Tablet 3 mg | Oral | ARX-GLIMEPIRIDE | XT | MP NP | | | 30 | 5 | | 30 | | |
Glimepiride | Tablet 3 mg | Oral | ARX-GLIMEPIRIDE | XT | MP NP | | P14238 | 60 | 5 | | 30 | | |
[52] Schedule 1, Part 1, entry for Glimepiride in the form Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Glimepiride | Tablet 4 mg | Oral | ARX-GLIMEPIRIDE | XT | MP NP | | | 30 | 5 | | 30 | | |
Glimepiride | Tablet 4 mg | Oral | ARX-GLIMEPIRIDE | XT | MP NP | | P14238 | 60 | 5 | | 30 | | |
[53] Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Glivec]
omit from the column headed “Responsible Person” (all instances): AF substitute (all instances): NV
[54] Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Glivec]
omit from the column headed “Responsible Person” (all instances): AF substitute (all instances): NV
[55] Schedule 1, Part 1, entry for Inclisiran in the form Injection 284 mg in 1.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 0]
(a) omit from the column headed “Circumstances”: C15313 C15323
(b) insert in numerical order in the column headed “Circumstances”: C15338 C15369
(c) omit from the column headed “Purposes”: P15313 P15323
(d) insert in numerical order in the column headed “Purposes”: P15338 P15369
[56] Schedule 1, Part 1, entry for Inclisiran in the form Injection 284 mg in 1.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C15315 C15331 substitute: C15430 C15443
(b) omit from the column headed “Purposes”: P15315 P15331 substitute: P15430 P15443
[57] Schedule 1, Part 1, entry for Leflunomide in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Leflunomide | Tablet 10 mg | Oral | APO-LEFLUNOMIDE | TX | MP | C13753 C13771 | P13753 P13771 | 30 | 5 | | 30 | | |
Leflunomide | Tablet 10 mg | Oral | APO-LEFLUNOMIDE | TX | MP | C14941 C14942 | P14941 P14942 | 60 | 5 | | 30 | | |
[58] Schedule 1, Part 1, entry for Leflunomide in the form Tablet 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Leflunomide | Tablet 20 mg | Oral | APO-LEFLUNOMIDE | TX | MP | C13753 C13771 | P13753 P13771 | 30 | 5 | | 30 | | |
Leflunomide | Tablet 20 mg | Oral | APO-LEFLUNOMIDE | TX | MP | C14941 C14942 | P14941 P14942 | 60 | 5 | | 30 | | |
[59] Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]
(a) omit from the column headed “Circumstances”: C14043
(b) omit from the column headed “Purposes”: P14043
[60] Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 10 mg (as mesilate)
omit from the column headed “Circumstances”: C14043
[61] Schedule 1, Part 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Oral | ARX-LERCANIDIPINE | TX | MP NP | | | 28 | 5 | | 28 | | |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Oral | ARX-LERCANIDIPINE | TX | MP NP | | P14238 | 56 | 5 | | 28 | | |
[62] Schedule 1, Part 1, entry for Letrozole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Letrozole | Tablet 2.5 mg | Oral | ARX-LETROZOLE | XT | MP NP | C5464 | P5464 | 30 | 5 | | 30 | | |
Letrozole | Tablet 2.5 mg | Oral | ARX-LETROZOLE | XT | MP NP | C14943 | P14943 | 60 | 5 | | 30 | | |
[63] Schedule 1, Part 1, entry for Levetiracetam in the form Tablet 250 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Levetiracetam | Tablet 250 mg | Oral | Levetiracetam Viatris | MQ | MP NP | C11116 | P11116 | 60 | 5 | | 60 | | |
Levetiracetam | Tablet 250 mg | Oral | Levetiracetam Viatris | MQ | MP NP | C14964 | P14964 | 120 | 5 | | 60 | | |
[64] Schedule 1, Part 1, entry for Levetiracetam in the form Tablet 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Levetiracetam | Tablet 1 g | Oral | Levetiracetam Viatris | MQ | MP NP | C11116 | P11116 | 60 | 5 | | 60 | | |
Levetiracetam | Tablet 1 g | Oral | Levetiracetam Viatris | MQ | MP NP | C14964 | P14964 | 120 | 5 | | 60 | | |
[65] Schedule 1, Part 1, entry for Medroxyprogesterone in the form Injection containing medroxyprogesterone acetate 150 mg in 1 mL
omit:
Medroxyprogesterone | Injection containing medroxyprogesterone acetate 150 mg in 1 mL | Injection | Depo-Ralovera | FZ | MP NP | | | 1 | 1 | | 1 | | |
[66] Schedule 1, Part 1, after entry for Mefenamic acid in the form Capsule 250 mg [Brand: Ponstan]
insert:
Melatonin | Tablet 1 mg (modified release) | Oral | Slenyto | AS | MP | C15333 C15363 | | 60 | 5 | | 60 | | |
Melatonin | Tablet 5 mg (modified release) | Oral | Slenyto | AS | MP | C15333 C15363 | | 30 | 5 | | 30 | | |
[67] Schedule 1, Part 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL
substitute:
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL | Oral | Aspen Methadone Syrup | AS | MP NP | C15358 | | 840 | 5 | | 1000 | | PB(100) |
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL | Oral | Biodone Forte | MW | MP NP | C15358 | | 840 | 5 | | 1000 | | PB(100) |
[68] Schedule 1, Part 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL
substitute:
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL | Oral | Aspen Methadone Syrup | AS | MP NP | C4941 | P4941 | 200 | 0 | | 200 | | |
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL | Oral | Aspen Methadone Syrup | AS | MP NP | C4902 | P4902 | 200 | 2 | | 200 | | |
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL | Oral | Aspen Methadone Syrup | AS | MP NP | C15358 | P15358 | 840 | 5 | | 200 | | C(100) |
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL | Oral | Biodone Forte | MW | MP NP | C15358 | | 840 | 5 | | 200 | | C(100) |
[69] Schedule 1, Part 1, after entry for Morphine in the form Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL [Brand: Ordine 5; Maximum Quantity: 400; Number of Repeats: 1]
insert:
Morphine | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL (S19A) | Oral | RA-Morph (NZ) | WZ | MP NP | C10764 C10770 C10777 | P10764 P10770 P10777 | 200 | 0 | | 200 | | |
Morphine | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL (S19A) | Oral | RA-Morph (NZ) | WZ | PDP | C10859 | | 200 | 0 | | 200 | | |
Morphine | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL (S19A) | Oral | RA-Morph (NZ) | WZ | MP NP | C11697 | P11697 | 400 | 1 | | 200 | | |
[70] Schedule 1, Part 1, after entry for Morphine in the form Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL [Brand: Ordine 10; Maximum Quantity: 400; Number of Repeats: 1]
insert:
Morphine | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (RA-Morph)(S19A) | Oral | RA-Morph (NZ) | WZ | MP NP | C10764 C10770 C10777 | P10764 P10770 P10777 | 200 | 0 | V10764 V10770 V10777 | 200 | | |
Morphine | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (RA-Morph)(S19A) | Oral | RA-Morph (NZ) | WZ | PDP | C10859 | | 200 | 0 | | 200 | | |
Morphine | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (RA-Morph)(S19A) | Oral | RA-Morph (NZ) | WZ | MP NP | C11697 | P11697 | 400 | 1 | V11697 | 200 | | |
[71] Schedule 1, Part 1, entry for Naltrexone
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Naltrexone | Tablet containing naltrexone hydrochloride 50 mg | Oral | ARX-NALTREXONE | XT | MP NP | C13967 | | 30 | 1 | | 30 | | |
[72] Schedule 1, Part 1, after entry for Niraparib in the form Capsule 100 mg (as tosilate monohydrate) [Maximum Quantity: 84; Number of Repeats: 5]
insert:
Niraparib | Tablet 100 mg (as tosilate monohydrate) | Oral | Zejula | GK | MP | C15414 C15440 | P15414 P15440 | 56 | 2 | | 56 | | |
Niraparib | Tablet 100 mg (as tosilate monohydrate) | Oral | Zejula | GK | MP | C15391 C15428 | P15391 P15428 | 56 | 5 | | 56 | | |
Niraparib | Tablet 100 mg (as tosilate monohydrate) | Oral | Zejula | GK | MP | C15408 P15441 | C15408 P15441 | 84 | 2 | | 84 | | |
Niraparib | Tablet 100 mg (as tosilate monohydrate) | Oral | Zejula | GK | MP | C15407 P15416 | C15407 P15416 | 84 | 5 | | 84 | | |
[73] Schedule 1, Part 1, after entry for Octreotide in the form Injection 50 micrograms (as acetate) in 1 mL [Brand: Sandostatin 0.05]
insert:
Octreotide | Injection 50 micrograms (as acetate) in 1 mL (S19A) | Injection | Octreotide Acetate Omega (Canada) | GQ | MP | C6369 C6390 C8165 C9232 C9233 C9289 | | 90 | 11 | | 5 | | D(100) |
[74] Schedule 1, Part 1, after entry for Octreotide in the form Injection 100 micrograms (as acetate) in 1 mL [Brand: Sandostatin 0.1]
insert:
Octreotide | Injection 100 micrograms (as acetate) in 1 mL (S19A) | Injection | Octreotide Acetate Omega (Canada) | GQ | MP | C6369 C6390 C8165 C9232 C9233 C9289 | | 90 | 11 | | 5 | | D(100) |
[75] Schedule 1, Part 1, entry for Octreotide in the form Injection 500 micrograms (as acetate) in 1 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Octreotide | Injection 500 micrograms (as acetate) in 1 mL | Injection | Octreotide Acetate Omega (Canada) | GQ | MP | C6369 C6390 C8165 C9232 C9233 C9289 | | 90 | 11 | | 5 | | D(100) |
[76] Schedule 1, Part 1, entry for Olanzapine in the form Tablet 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Olanzapine | Tablet 2.5 mg | Oral | APO-OLANZAPINE | TX | MP NP | C5856 C5869 | | 28 | 5 | | 28 | | |
[77] Schedule 1, Part 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C15370
(b) insert in numerical order in the column headed “Purposes”: P15370
[78] Schedule 1, Part 1, after entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 5]
insert:
Olaparib | Tablet 100 mg | Oral | Lynparza | AP | MP | C15371 | P15371 | 112 | 6 | | 56 | | |
[79] Schedule 1, Part 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C15370
(b) insert in numerical order in the column headed “Purposes”: P15370
[80] Schedule 1, Part 1, after entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 5]
insert:
Olaparib | Tablet 150 mg | Oral | Lynparza | AP | MP | C15371 | P15371 | 112 | 6 | | 56 | | |
[81] Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
substitute:
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | APO-Pantoprazole | TX | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | APO-Pantoprazole | TX | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | APO-Pantoprazole | TX | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | APX-PANTOPRAZOLE | TW | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | APX-PANTOPRAZOLE | TW | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | APX-PANTOPRAZOLE | TW | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | BTC Pantoprazole | BG | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | BTC Pantoprazole | BG | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | BTC Pantoprazole | BG | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | I-Pantoprazole | CR | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | I-Pantoprazole | CR | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | I-Pantoprazole | CR | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | NOUMED PANTOPRAZOLE | VO | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | NOUMED PANTOPRAZOLE | VO | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | NOUMED PANTOPRAZOLE | VO | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Ozpan | RA | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Ozpan | RA | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Ozpan | RA | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Panthron | ZS | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Panthron | ZS | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Panthron | ZS | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Pantoprazole APOTEX | TY | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Pantoprazole APOTEX | TY | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Pantoprazole APOTEX | TY | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Pantoprazole generichealth | HQ | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Pantoprazole generichealth | HQ | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Pantoprazole generichealth | HQ | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Pantoprazole Sandoz | SZ | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Pantoprazole Sandoz | SZ | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Pantoprazole Sandoz | SZ | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Salpraz | AF | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Salpraz | AF | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Salpraz | AF | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Somac | NQ | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Somac | NQ | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Somac | NQ | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Sozol | RW | MP NP | C8774 C8775 | P8774 P8775 | 30 | 1 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Sozol | RW | MP NP | C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | | 30 | | |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | Sozol | RW | MP | C11310 | P11310 | 60 | 5 | | 30 | | |
[82] Schedule 1, Part 1, entry for Pembrolizumab [6th row of entry]
(a) omit from the column headed “Circumstances”: C14028
(b) omit from the column headed “Purposes”: P14028
[83] Schedule 1, Part 1, entry for Phenoxymethylpenicillin
omit:
Phenoxymethylpenicillin | Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL (s19A) | Oral | Penopen | QY | PDP | | | 2 | 0 | | 1 | | |
Phenoxymethylpenicillin | Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL (s19A) | Oral | Penopen | QY | MP NP | | | 2 | 1 | | 1 | | |
[84] Schedule 1, Part 1, entry for Pirfenidone in the form Tablet 801mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pirfenidone | Tablet 801mg | Oral | Pirfenidone Dr.Reddy's | RZ | MP | C13380 | | 90 | 5 | | 90 | | |
[85] Schedule 1, Part 1, entry for Pirfenidone in the form Tablet 267 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pirfenidone | Tablet 267 mg | Oral | Pirfenidone Dr.Reddy's | RZ | MP | C13378 C13380 C13381 | | 270 | 5 | | 90 | | |
[86] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rosuvastatin | Tablet 20 mg (as calcium) | Oral | APO-ROSUVASTATIN | TX | MP NP | | | 30 | 5 | | 30 | | |
Rosuvastatin | Tablet 20 mg (as calcium) | Oral | APO-ROSUVASTATIN | TX | MP NP | | P14238 | 60 | 5 | | 30 | | |
[87] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rosuvastatin | Tablet 40 mg (as calcium) | Oral | APO-ROSUVASTATIN | TX | MP NP | | | 30 | 5 | | 30 | | |
Rosuvastatin | Tablet 40 mg (as calcium) | Oral | APO-ROSUVASTATIN | TX | MP NP | | P14238 | 60 | 5 | | 30 | | |
[88] Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 150 mg
omit:
Roxithromycin | Tablet 150 mg | Oral | Roximycin | AF | MP NP | | | 10 | 0 | | 10 | | |
Roxithromycin | Tablet 150 mg | Oral | Roximycin | AF | PDP | | | 10 | 0 | | 10 | | |
Roxithromycin | Tablet 150 mg | Oral | Roximycin | AF | MP NP | | P10404 | 20
CN10404 | 0
CN10404 | | 10 | | |
[89] Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg
omit:
Roxithromycin | Tablet 300 mg | Oral | Roximycin | AF | MP NP | | | 5 | 0 | | 5 | | |
Roxithromycin | Tablet 300 mg | Oral | Roximycin | AF | PDP | | | 5 | 0 | | 5 | | |
Roxithromycin | Tablet 300 mg | Oral | Roximycin | AF | MP NP | | P10404 | 10
CN10404 | 0
CN10404 | | 5 | | |
[90] Schedule 1, Part 1, entry for Sevelamer in the form Tablet containing sevelamer carbonate 800 mg
substitute:
Sevelamer | Tablet containing sevelamer carbonate 800 mg | Oral | ARX-SEVELAMER | XT | MP NP | C5491 | P5491 | 180 | 5 | | 180 | | |
Sevelamer | Tablet containing sevelamer carbonate 800 mg | Oral | ARX-SEVELAMER | XT | MP | C5530 C9762 | P5530 P9762 | 360 | 5 | | 180 | | C(100) |
Sevelamer | Tablet containing sevelamer carbonate 800 mg | Oral | ARX-SEVELAMER | XT | MP NP | C14984 | P14984 | 360 | 5 | | 180 | | |
Sevelamer | Tablet containing sevelamer carbonate 800 mg | Oral | Sevelamer Apotex | TX | MP NP | C5491 | P5491 | 180 | 5 | | 180 | | |
Sevelamer | Tablet containing sevelamer carbonate 800 mg | Oral | Sevelamer Apotex | TX | MP | C5530 C9762 | P5530 P9762 | 360 | 5 | | 180 | | C(100) |
Sevelamer | Tablet containing sevelamer carbonate 800 mg | Oral | Sevelamer Apotex | TX | MP NP | C14984 | P14984 | 360 | 5 | | 180 | | |
Sevelamer | Tablet containing sevelamer carbonate 800 mg | Oral | Sevelamer Lupin | GQ | MP NP | C5491 | P5491 | 180 | 5 | | 180 | | |
Sevelamer | Tablet containing sevelamer carbonate 800 mg | Oral | Sevelamer Lupin | GQ | MP | C5530 C9762 | P5530 P9762 | 360 | 5 | | 180 | | C(100) |
Sevelamer | Tablet containing sevelamer carbonate 800 mg | Oral | Sevelamer Lupin | GQ | MP NP | C14984 | P14984 | 360 | 5 | | 180 | | |
[91] Schedule 1, Part 1, entry for Sitagliptin in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sitagliptin | Tablet 25 mg | Oral | Sitagliptin Mylan | AF | MP NP | C15261 | P15261 | 28 | 5 | | 28 | | |
Sitagliptin | Tablet 25 mg | Oral | Sitagliptin Mylan | AF | MP NP | C15287 | P15287 | 56 | 5 | | 28 | | |
[92] Schedule 1, Part 1, entry for Sitagliptin in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sitagliptin | Tablet 50 mg | Oral | Sitagliptin Mylan | AF | MP NP | C15261 | P15261 | 28 | 5 | | 28 | | |
Sitagliptin | Tablet 50 mg | Oral | Sitagliptin Mylan | AF | MP NP | C15287 | P15287 | 56 | 5 | | 28 | | |
[93] Schedule 1, Part 1, entry for Sitagliptin in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sitagliptin | Tablet 100 mg | Oral | Sitagliptin Mylan | AF | MP NP | C15261 | P15261 | 28 | 5 | | 28 | | |
Sitagliptin | Tablet 100 mg | Oral | Sitagliptin Mylan | AF | MP NP | C15287 | P15287 | 56 | 5 | | 28 | | |
[94] Schedule 1, Part 1, entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride | Oral | Sitagliptin/Metformin Mylan 50/1000 | AF | MP NP | C15276 | P15276 | 56 | 5 | | 56 | | |
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride | Oral | Sitagliptin/Metformin Mylan 50/1000 | AF | MP NP | C15288 | P15288 | 112 | 5 | | 56 | | |
[95] Schedule 1, Part 1, entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride | Oral | Sitagliptin/Metformin Mylan 50/500 | AF | MP NP | C15276 | P15276 | 56 | 5 | | 56 | | |
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride | Oral | Sitagliptin/Metformin Mylan 50/500 | AF | MP NP | C15288 | P15288 | 112 | 5 | | 56 | | |
[96] Schedule 1, Part 1, entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride | Oral | Sitagliptin/Metformin Mylan 50/850 | AF | MP NP | C15276 | P15276 | 56 | 5 | | 56 | | |
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride | Oral | Sitagliptin/Metformin Mylan 50/850 | AF | MP NP | C15288 | P15288 | 112 | 5 | | 56 | | |
[97] Schedule 1, Part 1, entry for Tafamidis
(a) omit from the column headed “Circumstances”: C15157
(b) insert in numerical order in the column headed “Circumstances”: C15362
[98] Schedule 1, Part 1, entry for Teriparatide
omit:
Teriparatide | Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge | Injection | Terrosa | FX | MP | C12270 C12492 | P12270 P12492 | 1 | 5 | | 1 | | |
Teriparatide | Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge | Injection | Terrosa | FX | MP | C14997 | P14997 | 2 | 2 | | 1 | | |
[99] Schedule 1, Part 1, entry for Testosterone in the form I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL [Brand: Reandron 1000]
omit from the column headed “Responsible Person”: BN substitute: AS
[100] Schedule 1, Part 1, entry for Topiramate in the form Tablet 25 mg
omit:
Topiramate | Tablet 25 mg | Oral | NOUMED TOPIRAMATE | VO | MP NP | C5325 C5516 | P5325 P5516 | 60 | 5 | | 60 | | |
Topiramate | Tablet 25 mg | Oral | NOUMED TOPIRAMATE | VO | MP NP | C14901 C14973 | P14901 P14973 | 120 | 5 | | 60 | | |
[101] Schedule 1, Part 1, entry for Topiramate in the form Tablet 50 mg
omit:
Topiramate | Tablet 50 mg | Oral | NOUMED TOPIRAMATE | VO | MP NP | C5325 C5516 | P5325 P5516 | 60 | 5 | | 60 | | |
Topiramate | Tablet 50 mg | Oral | NOUMED TOPIRAMATE | VO | MP NP | C14901 C14973 | P14901 P14973 | 120 | 5 | | 60 | | |
[102] Schedule 1, Part 1, entry for Topiramate in the form Tablet 100 mg
omit:
Topiramate | Tablet 100 mg | Oral | NOUMED TOPIRAMATE | VO | MP NP | C5325 C5516 | P5325 P5516 | 60 | 5 | | 60 | | |
Topiramate | Tablet 100 mg | Oral | NOUMED TOPIRAMATE | VO | MP NP | C14901 C14973 | P14901 P14973 | 120 | 5 | | 60 | | |
[103] Schedule 1, Part 1, entry for Topiramate in the form Tablet 200 mg
omit:
Topiramate | Tablet 200 mg | Oral | NOUMED TOPIRAMATE | VO | MP NP | C5516 | P5516 | 60 | 5 | | 60 | | |
Topiramate | Tablet 200 mg | Oral | NOUMED TOPIRAMATE | VO | MP NP | C14973 | P14973 | 120 | 5 | | 60 | | |
[104] Schedule 1, Part 1, entry for Varenicline
omit:
Varenicline | Tablet 0.5 mg (as tartrate) (s19A) | Oral | APO-Varenicline (Canada) | XT | MP NP | C6871 | | 112 | 0 | | 56 | | |
[105] Schedule 1, Part 1, entry for Varenicline in the form Tablet 1 mg (as tartrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Varenicline | Tablet 1 mg (as tartrate) | Oral | Varenicline Viatris | AF | MP NP | C6885 | P6885 | 56 | 2 | | 56 | | |
Varenicline | Tablet 1 mg (as tartrate) | Oral | Varenicline Viatris | AF | MP NP | C7483 | P7483 | 112 | 0 | | 56 | | |
[106] Schedule 1, Part 2
insert as first entry:
Acalabrutinib | Capsule 100 mg | Oral | Calquence | AP | 56 | | |
[107] Schedule 1, Part 2, omit entry for Capecitabine
[108] Schedule 1, Part 2, omit entry for Varenicline
[109] Schedule 3, after details relevant for Responsible Person code IY
insert:
JA | JAZZ PHARMACEUTICALS ANZ PTY LTD | 83 643 560 534 |
[110] Schedule 4, Part 1, omit entry for Circumstances Code “C4524”
[111] Schedule 4, Part 1, omit entry for Circumstances Code “C7046”
[112] Schedule 4, Part 1, omit entry for Circumstances Code “C7055”
[113] Schedule 4, Part 1, omit entry for Circumstances Code “C7087”
[114] Schedule 4, Part 1, omit entry for Circumstances Code “C7777”
[115] Schedule 4, Part 1, omit entry for Circumstances Code “C8296”
[116] Schedule 4, Part 1, omit entry for Circumstances Code “C8844”
[117] Schedule 4, Part 1, omit entry for Circumstances Code “C8881”
[118] Schedule 4, Part 1, omit entry for Circumstances Code “C8883”
[119] Schedule 4, Part 1, omit entry for Circumstances Code “C8940”
[120] Schedule 4, Part 1, omit entry for Circumstances Code “C8941”
[121] Schedule 4, Part 1, omit entry for Circumstances Code “C8962”
[122] Schedule 4, Part 1, omit entry for Circumstances Code “C9041”
[123] Schedule 4, Part 1, omit entry for Circumstances Code “C9065”
[124] Schedule 4, Part 1, omit entry for Circumstances Code “C9067”
[125] Schedule 4, Part 1, omit entry for Circumstances Code “C9068”
[126] Schedule 4, Part 1, omit entry for Circumstances Code “C9088”
[127] Schedule 4, Part 1, omit entry for Circumstances Code “C9089”
[128] Schedule 4, Part 1, omit entry for Circumstances Code “C9111”
[129] Schedule 4, Part 1, omit entry for Circumstances Code “C9188”
[130] Schedule 4, Part 1, omit entry for Circumstances Code “C9407”
[131] Schedule 4, Part 1, entry for Circumstances Code “C9417”
omit from the column headed “Listed Drug”: Tocilizumab
[132] Schedule 4, Part 1, omit entry for Circumstances Code “C9472”
[133] Schedule 4, Part 1, omit entry for Circumstances Code “C9494”
[134] Schedule 4, Part 1, omit entry for Circumstances Code “C9495”
[135] Schedule 4, Part 1, omit entry for Circumstances Code “C9559”
[136] Schedule 4, Part 1, omit entry for Circumstances Code “C9584”
[137] Schedule 4, Part 1, omit entry for Circumstances Code “C9602”
[138] Schedule 4, Part 1, omit entry for Circumstances Code “C9632”
[139] Schedule 4, Part 1, omit entry for Circumstances Code “C9668”
[140] Schedule 4, Part 1, omit entry for Circumstances Code “C9669”
[141] Schedule 4, Part 1, omit entry for Circumstances Code “C9677”
[142] Schedule 4, Part 1, omit entry for Circumstances Code “C9719”
[143] Schedule 4, Part 1, omit entry for Circumstances Code “C9721”
[144] Schedule 4, Part 1, omit entry for Circumstances Code “C9732”
[145] Schedule 4, Part 1, omit entry for Circumstances Code “C9738”
[146] Schedule 4, Part 1, omit entry for Circumstances Code “C9751”
[147] Schedule 4, Part 1, omit entry for Circumstances Code “C9754”
[148] Schedule 4, Part 1, omit entry for Circumstances Code “C9771”
[149] Schedule 4, Part 1, omit entry for Circumstances Code “C9775”
[150] Schedule 4, Part 1, omit entry for Circumstances Code “C9779”
[151] Schedule 4, Part 1, omit entry for Circumstances Code “C9783”
[152] Schedule 4, Part 1, omit entry for Circumstances Code “C9787”
[153] Schedule 4, Part 1, omit entry for Circumstances Code “C9803”
[154] Schedule 4, Part 1, omit entry for Circumstances Code “C10223”
[155] Schedule 4, Part 1, omit entry for Circumstances Code “C10226”
[156] Schedule 4, Part 1, omit entry for Circumstances Code “C10265”
[157] Schedule 4, Part 1, omit entry for Circumstances Code “C10570”
[158] Schedule 4, Part 1, entry for Circumstances Code “C11138”
omit entry for Circumstances Code “C11138” and substitute:
C11138 | P11138 | CN11138 | Ixekizumab Secukinumab | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or re-commencement 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 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND 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. 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 baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include (a) a completed authority prescription form(s); 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. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 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 |
[159] Schedule 4, Part 1, omit entry for Circumstances Code “C11158”
[160] Schedule 4, Part 1, omit entry for Circumstances Code “C11193”
[161] Schedule 4, Part 1, omit entry for Circumstances Code “C11195”
[162] Schedule 4, Part 1, omit entry for Circumstances Code “C11261”
[163] Schedule 4, Part 1, omit entry for Circumstances Code “C11699”
[164] Schedule 4, Part 1, omit entry for Circumstances Code “C11844”
[165] Schedule 4, Part 1, omit entry for Circumstances Code “C11846”
[166] Schedule 4, Part 1, omit entry for Circumstances Code “C11847”
[167] Schedule 4, Part 1, omit entry for Circumstances Code “C11892”
[168] Schedule 4, Part 1, omit entry for Circumstances Code “C11893”
[169] Schedule 4, Part 1, omit entry for Circumstances Code “C11897”
[170] Schedule 4, Part 1, omit entry for Circumstances Code “C11902”
[171] Schedule 4, Part 1, omit entry for Circumstances Code “C11924”
[172] Schedule 4, Part 1, omit entry for Circumstances Code “C11926”
[173] Schedule 4, Part 1, omit entry for Circumstances Code “C11964”
[174] Schedule 4, Part 1, omit entry for Circumstances Code “C11999”
[175] Schedule 4, Part 1, omit entry for Circumstances Code “C12003”
[176] Schedule 4, Part 1, omit entry for Circumstances Code “C12025”
[177] Schedule 4, Part 1, omit entry for Circumstances Code “C12042”
[178] Schedule 4, Part 1, omit entry for Circumstances Code “C12043”
[179] Schedule 4, Part 1, omit entry for Circumstances Code “C12063”
[180] Schedule 4, Part 1, omit entry for Circumstances Code “C12069”
[181] Schedule 4, Part 1, omit entry for Circumstances Code “C12074”
[182] Schedule 4, Part 1, omit entry for Circumstances Code “C12080”
[183] Schedule 4, Part 1, omit entry for Circumstances Code “C12083”
[184] Schedule 4, Part 1, omit entry for Circumstances Code “C12135”
[185] Schedule 4, Part 1, omit entry for Circumstances Code “C12137”
[186] Schedule 4, Part 1, omit entry for Circumstances Code “C12163”
[187] Schedule 4, Part 1, omit entry for Circumstances Code “C12179”
[188] Schedule 4, Part 1, omit entry for Circumstances Code “C12219”
[189] Schedule 4, Part 1, omit entry for Circumstances Code “C12220”
[190] Schedule 4, Part 1, omit entry for Circumstances Code “C12221”
[191] Schedule 4, Part 1, omit entry for Circumstances Code “C12313”
[192] Schedule 4, Part 1, omit entry for Circumstances Code “C12425”
[193] Schedule 4, Part 1, omit entry for Circumstances Code “C12436”
[194] Schedule 4, Part 1, omit entry for Circumstances Code “C12450”
[195] Schedule 4, Part 1, omit entry for Circumstances Code “C12451”
[196] Schedule 4, Part 1, omit entry for Circumstances Code “C12609”
[197] Schedule 4, Part 1, omit entry for Circumstances Code “C12614”
[198] Schedule 4, Part 1, omit entry for Circumstances Code “C12630”
[199] Schedule 4, Part 1, omit entry for Circumstances Code “C12635”
[200] Schedule 4, Part 1, omit entry for Circumstances Code “C12639”
[201] Schedule 4, Part 1, omit entry for Circumstances Code “C12672”
[202] Schedule 4, Part 1, omit entry for Circumstances Code “C12676”
[203] Schedule 4, Part 1, omit entry for Circumstances Code “C13001”
[204] Schedule 4, Part 1, omit entry for Circumstances Code “C13013”
[205] Schedule 4, Part 1, omit entry for Circumstances Code “C13222”
[206] Schedule 4, Part 1, omit entry for Circumstances Code “C13270”
[207] Schedule 4, Part 1, omit entry for Circumstances Code “C13330”
[208] Schedule 4, Part 1, omit entry for Circumstances Code “C13396”
[209] Schedule 4, Part 1, omit entry for Circumstances Code “C13458”
[210] Schedule 4, Part 1, omit entry for Circumstances Code “C13459”
[211] Schedule 4, Part 1, omit entry for Circumstances Code “C13464”
[212] Schedule 4, Part 1, omit entry for Circumstances Code “C13469”
[213] Schedule 4, Part 1, omit entry for Circumstances Code “C13482”
[214] Schedule 4, Part 1, omit entry for Circumstances Code “C13484”
[215] Schedule 4, Part 1, omit entry for Circumstances Code “C13495”
[216] Schedule 4, Part 1, omit entry for Circumstances Code “C13518”
[217] Schedule 4, Part 1, omit entry for Circumstances Code “C13526”
[218] Schedule 4, Part 1, omit entry for Circumstances Code “C13560”
[219] Schedule 4, Part 1, omit entry for Circumstances Code “C13569”
[220] Schedule 4, Part 1, omit entry for Circumstances Code “C13570”
[221] Schedule 4, Part 1, omit entry for Circumstances Code “C13571”
[222] Schedule 4, Part 1, omit entry for Circumstances Code “C13572”
[223] Schedule 4, Part 1, omit entry for Circumstances Code “C13573”
[224] Schedule 4, Part 1, omit entry for Circumstances Code “C13584”
[225] Schedule 4, Part 1, omit entry for Circumstances Code “C13586”
[226] Schedule 4, Part 1, omit entry for Circumstances Code “C13587”
[227] Schedule 4, Part 1, omit entry for Circumstances Code “C13616”
[228] Schedule 4, Part 1, omit entry for Circumstances Code “C13629”
[229] Schedule 4, Part 1, omit entry for Circumstances Code “C13632”
[230] Schedule 4, Part 1, omit entry for Circumstances Code “C13639”
[231] Schedule 4, Part 1, omit entry for Circumstances Code “C13640”
[232] Schedule 4, Part 1, omit entry for Circumstances Code “C13641”
[233] Schedule 4, Part 1, omit entry for Circumstances Code “C13655”
[234] Schedule 4, Part 1, omit entry for Circumstances Code “C13660”
[235] Schedule 4, Part 1, omit entry for Circumstances Code “C13661”
[236] Schedule 4, Part 1, omit entry for Circumstances Code “C13684”
[237] Schedule 4, Part 1, omit entry for Circumstances Code “C13691”
[238] Schedule 4, Part 1, omit entry for Circumstances Code “C13692”
[239] Schedule 4, Part 1, omit entry for Circumstances Code “C13702”
[240] Schedule 4, Part 1, omit entry for Circumstances Code “C13710”
[241] Schedule 4, Part 1, omit entry for Circumstances Code “C13719”
[242] Schedule 4, Part 1, omit entry for Circumstances Code “C13743”
[243] Schedule 4, Part 1, omit entry for Circumstances Code “C13746”
[244] Schedule 4, Part 1, omit entry for Circumstances Code “C13755”
[245] Schedule 4, Part 1, omit entry for Circumstances Code “C13757”
[246] Schedule 4, Part 1, omit entry for Circumstances Code “C13768”
[247] Schedule 4, Part 1, omit entry for Circumstances Code “C13782”
[248] Schedule 4, Part 1, omit entry for Circumstances Code “C13785”
[249] Schedule 4, Part 1, omit entry for Circumstances Code “C13786”
[250] Schedule 4, Part 1, omit entry for Circumstances Code “C13787”
[251] Schedule 4, Part 1, omit entry for Circumstances Code “C13791”
[252] Schedule 4, Part 1, omit entry for Circumstances Code “C13801”
[253] Schedule 4, Part 1, omit entry for Circumstances Code “C13803”
[254] Schedule 4, Part 1, omit entry for Circumstances Code “C13804”
[255] Schedule 4, Part 1, omit entry for Circumstances Code “C13805”
[256] Schedule 4, Part 1, omit entry for Circumstances Code “C13810”
[257] Schedule 4, Part 1, omit entry for Circumstances Code “C13811”
[258] Schedule 4, Part 1, omit entry for Circumstances Code “C13812”
[259] Schedule 4, Part 1, omit entry for Circumstances Code “C13813”
[260] Schedule 4, Part 1, omit entry for Circumstances Code “C13845”
[261] Schedule 4, Part 1, omit entry for Circumstances Code “C13857”
[262] Schedule 4, Part 1, omit entry for Circumstances Code “C13932”
[263] Schedule 4, Part 1, omit entry for Circumstances Code “C13962”
[264] Schedule 4, Part 1, omit entry for Circumstances Code “C13975”
[265] Schedule 4, Part 1, omit entry for Circumstances Code “C13976”
[266] Schedule 4, Part 1, omit entry for Circumstances Code “C13980”
[267] Schedule 4, Part 1, omit entry for Circumstances Code “C13991”
[268] Schedule 4, Part 1, omit entry for Circumstances Code “C14010”
[269] Schedule 4, Part 1, omit entry for Circumstances Code “C14028”
[270] Schedule 4, Part 1, omit entry for Circumstances Code “C14043”
[271] Schedule 4, Part 1, omit entry for Circumstances Code “C14074”
[272] Schedule 4, Part 1, omit entry for Circumstances Code “C14075”
[273] Schedule 4, Part 1, omit entry for Circumstances Code “C14082”
[274] Schedule 4, Part 1, omit entry for Circumstances Code “C14083”
[275] Schedule 4, Part 1, omit entry for Circumstances Code “C14085”
[276] Schedule 4, Part 1, omit entry for Circumstances Code “C14091”
[277] Schedule 4, Part 1, omit entry for Circumstances Code “C14093”
[278] Schedule 4, Part 1, omit entry for Circumstances Code “C14098”
[279] Schedule 4, Part 1, omit entry for Circumstances Code “C14099”
[280] Schedule 4, Part 1, omit entry for Circumstances Code “C14138”
[281] Schedule 4, Part 1, omit entry for Circumstances Code “C14139”
[282] Schedule 4, Part 1, omit entry for Circumstances Code “C14145”
[283] Schedule 4, Part 1, omit entry for Circumstances Code “C14148”
[284] Schedule 4, Part 1, omit entry for Circumstances Code “C14149”
[285] Schedule 4, Part 1, omit entry for Circumstances Code “C14157”
[286] Schedule 4, Part 1, omit entry for Circumstances Code “C14162”
[287] Schedule 4, Part 1, omit entry for Circumstances Code “C14164”
[288] Schedule 4, Part 1, omit entry for Circumstances Code “C14178”
[289] Schedule 4, Part 1, omit entry for Circumstances Code “C14179”
[290] Schedule 4, Part 1, omit entry for Circumstances Code “C14359”
[291] Schedule 4, Part 1, omit entry for Circumstances Code “C14360”
[292] Schedule 4, Part 1, omit entry for Circumstances Code “C14362”
[293] Schedule 4, Part 1, omit entry for Circumstances Code “C14368”
[294] Schedule 4, Part 1, omit entry for Circumstances Code “C14370”
[295] Schedule 4, Part 1, omit entry for Circumstances Code “C14372”
[296] Schedule 4, Part 1, omit entry for Circumstances Code “C14392”
[297] Schedule 4, Part 1, omit entry for Circumstances Code “C14408”
[298] Schedule 4, Part 1, omit entry for Circumstances Code “C14420”
[299] Schedule 4, Part 1, omit entry for Circumstances Code “C14421”
[300] Schedule 4, Part 1, omit entry for Circumstances Code “C14433”
[301] Schedule 4, Part 1, omit entry for Circumstances Code “C14435”
[302] Schedule 4, Part 1, omit entry for Circumstances Code “C14458”
[303] Schedule 4, Part 1, omit entry for Circumstances Code “C14459”
[304] Schedule 4, Part 1, omit entry for Circumstances Code “C14468”
[305] Schedule 4, Part 1, omit entry for Circumstances Code “C14469”
[306] Schedule 4, Part 1, omit entry for Circumstances Code “C14476”
[307] Schedule 4, Part 1, omit entry for Circumstances Code “C14477”
[308] Schedule 4, Part 1, omit entry for Circumstances Code “C14485”
[309] Schedule 4, Part 1, omit entry for Circumstances Code “C14487”
[310] Schedule 4, Part 1, omit entry for Circumstances Code “C14489”
[311] Schedule 4, Part 1, omit entry for Circumstances Code “C14491”
[312] Schedule 4, Part 1, omit entry for Circumstances Code “C14502”
[313] Schedule 4, Part 1, omit entry for Circumstances Code “C14504”
[314] Schedule 4, Part 1, omit entry for Circumstances Code “C14505”
[315] Schedule 4, Part 1, omit entry for Circumstances Code “C14530”
[316] Schedule 4, Part 1, omit entry for Circumstances Code “C14531”
[317] Schedule 4, Part 1, omit entry for Circumstances Code “C14534”
[318] Schedule 4, Part 1, omit entry for Circumstances Code “C14538”
[319] Schedule 4, Part 1, omit entry for Circumstances Code “C14544”
[320] Schedule 4, Part 1, omit entry for Circumstances Code “C14546”
[321] Schedule 4, Part 1, omit entry for Circumstances Code “C14547”
[322] Schedule 4, Part 1, omit entry for Circumstances Code “C14548”
[323] Schedule 4, Part 1, omit entry for Circumstances Code “C14565”
[324] Schedule 4, Part 1, omit entry for Circumstances Code “C14585”
[325] Schedule 4, Part 1, omit entry for Circumstances Code “C14586”
[326] Schedule 4, Part 1, omit entry for Circumstances Code “C14597”
[327] Schedule 4, Part 1, omit entry for Circumstances Code “C14615”
[328] Schedule 4, Part 1, omit entry for Circumstances Code “C14621”
[329] Schedule 4, Part 1, omit entry for Circumstances Code “C14623”
[330] Schedule 4, Part 1, omit entry for Circumstances Code “C14632”
[331] Schedule 4, Part 1, omit entry for Circumstances Code “C14638”
[332] Schedule 4, Part 1, omit entry for Circumstances Code “C14667”
[333] Schedule 4, Part 1, entry for Circumstances Code “C14683”
omit from the column headed “Listed Drug”: Infliximab
[334] Schedule 4, Part 1, omit entry for Circumstances Code “C14689”
[335] Schedule 4, Part 1, entry for Circumstances Code “C14701”
omit from the column headed “Listed Drug”: Infliximab
[336] Schedule 4, Part 1, omit entry for Circumstances Code “C14705”
[337] Schedule 4, Part 1, omit entry for Circumstances Code “C14707”
[338] Schedule 4, Part 1, omit entry for Circumstances Code “C14716”
[339] Schedule 4, Part 1, omit entry for Circumstances Code “C14718”
[340] Schedule 4, Part 1, omit entry for Circumstances Code “C14723”
[341] Schedule 4, Part 1, omit entry for Circumstances Code “C14724”
[342] Schedule 4, Part 1, omit entry for Circumstances Code “C14737”
[343] Schedule 4, Part 1, omit entry for Circumstances Code “C14744”
[344] Schedule 4, Part 1, omit entry for Circumstances Code “C14746”
[345] Schedule 4, Part 1, omit entry for Circumstances Code “C14747”
[346] Schedule 4, Part 1, omit entry for Circumstances Code “C14748”
[347] Schedule 4, Part 1, omit entry for Circumstances Code “C14749”
[348] Schedule 4, Part 1, omit entry for Circumstances Code “C14750”
[349] Schedule 4, Part 1, omit entry for Circumstances Code “C14753”
[350] Schedule 4, Part 1, omit entry for Circumstances Code “C14754”
[351] Schedule 4, Part 1, omit entry for Circumstances Code “C14757”
[352] Schedule 4, Part 1, omit entry for Circumstances Code “C14765”
[353] Schedule 4, Part 1, omit entry for Circumstances Code “C14780”
[354] Schedule 4, Part 1, omit entry for Circumstances Code “C14781”
[355] Schedule 4, Part 1, omit entry for Circumstances Code “C14783”
[356] Schedule 4, Part 1, omit entry for Circumstances Code “C14784”
[357] Schedule 4, Part 1, omit entry for Circumstances Code “C14785”
[358] Schedule 4, Part 1, omit entry for Circumstances Code “C14791”
[359] Schedule 4, Part 1, omit entry for Circumstances Code “C14792”
[360] Schedule 4, Part 1, omit entry for Circumstances Code “C14793”
[361] Schedule 4, Part 1, omit entry for Circumstances Code “C14796”
[362] Schedule 4, Part 1, omit entry for Circumstances Code “C14797”
[363] Schedule 4, Part 1, omit entry for Circumstances Code “C14799”
[364] Schedule 4, Part 1, omit entry for Circumstances Code “C14805”
[365] Schedule 4, Part 1, omit entry for Circumstances Code “C14997”
[366] Schedule 4, Part 1, omit entry for Circumstances Code “C15066”
[367] Schedule 4, Part 1, omit entry for Circumstances Code “C15069”
[368] Schedule 4, Part 1, omit entry for Circumstances Code “C15079”
[369] Schedule 4, Part 1, omit entry for Circumstances Code “C15092”
[370] Schedule 4, Part 1, omit entry for Circumstances Code “C15095”
[371] Schedule 4, Part 1, omit entry for Circumstances Code “C15106”
[372] Schedule 4, Part 1, omit entry for Circumstances Code “C15107”
[373] Schedule 4, Part 1, omit entry for Circumstances Code “C15112”
[374] Schedule 4, Part 1, omit entry for Circumstances Code “C15116”
[375] Schedule 4, Part 1, omit entry for Circumstances Code “C15157”
[376] Schedule 4, Part 1, omit entry for Circumstances Code “C15313”
[377] Schedule 4, Part 1, omit entry for Circumstances Code “C15315”
[378] Schedule 4, Part 1, omit entry for Circumstances Code “C15323”
[379] Schedule 4, Part 1, omit entry for Circumstances Code “C15330”
[380] Schedule 4, Part 1, omit entry for Circumstances Code “C15331”
[381] Schedule 4, Part 1, after entry for Circumstances Code “C15329”
insert:
C15333 | P15333 | CN15333 | Melatonin | Insomnia Initial Patient must have Smith-Magenis Syndrome confirmed by genetic testing; AND The condition must be inadequately responsive to sleep hygiene measures, resulting in the patient experiencing a period of at least 12 consecutive weeks of impaired sleep (see definition of impaired sleep below). Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types. Patient must be at least 2 years of age, but yet to turn 18 years of age, at treatment initiation with this drug. Definition: For the purposes of administering this restriction, Smith-Magenis Syndrome is confirmed by the deletion or variation of the retinoic acid induced 1 (RAI1) gene on chromosome 17p11.2 Definition:For the purposes of administering this restriction, impaired sleep is at least one of:(i) less than 6 hours of continuous sleep on at least 3 occasions over a given 5-day interval; (ii) taking at least half an hour to fall asleep on at least 3 occasions over a given 5-day interval. Prior to seeking authorisation for this pharmaceutical benefit, document the amount of continuous sleep/sleep latency in the patient's medical records for a period of 2 consecutive weeks, but ensure the impairment has been observed for at least 12 consecutive weeks. The documented values (averages) will form baseline measurements upon which the extent of response to treatment is to be considered under the Continuing treatment listing. The observations of continuous sleep/sleep latency may be based on any of the following, including a mix of: patient self-reporting, parental observation, documented medical history, sleep studies conducted by health professionals. | Compliance with Authority Required procedures |
C15338 | P15338 | CN15338 | Inclisiran | Non-familial hypercholesterolaemia Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2024; AND The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have had symptomatic atherosclerotic cardiovascular disease prior to starting non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had an LDL cholesterol level in excess of 1.8 millimoles per litre prior to starting non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories) prior to starting non-PBS-subsidised treatment with this drug for this condition; OR Patient must have had severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels prior to starting non-PBS-subsidised treatment with this drug for this condition; OR Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years prior to starting non-PBS-subsidised treatment with this drug for this condition; OR Patient must have had diabetes mellitus with microalbuminuria prior to starting non-PBS-subsidised treatment with this drug for this condition; OR Patient must have had diabetes mellitus and be aged 60 years of more prior to starting non-PBS-subsidised treatment with this drug for this condition; OR Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus that was present prior to starting non-PBS-subsidised treatment with this drug for this condition; OR Patient must have had a Thrombolysis in Myocardial Infarction (TIMI) Risk Score for Secondary Prevention of 4 or higher prior to starting non-PBS-subsidised treatment with this drug for this condition; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must have developed a clinically important product-related adverse event necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication. Must be treated by a specialist physician; OR Must be treated by a physician who has consulted a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level must have been measured following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events), must be stated at the time of application, documented in the patient's medical records and must have been no more than 8 weeks old at the time non-PBS-subsidised treatment with this drug for this condition was initiated. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin resulted in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must have been treated with the alternative statin (atorvastatin or rosuvastatin) unless there was a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should have occurred after a washout period of at least 4 weeks, or if the creatine kinase (CK) level was elevated, the retrial should not have occurred until CK had returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. One or more of the following must be stated at the time of application and documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event: (i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or (ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or (iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or (iv) diabetes mellitus with microalbuminuria; or (v) diabetes mellitus and age 60 years or more; or (vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or (vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures |
C15341 | P15341 | CN15341 | Dupilumab | Uncontrolled severe asthma Initial treatment - Initial 2 (Change of treatment) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and (c) if applicable, the eosinophil count and date; and (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (e) if applicable, the IgE result and date; and (f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). | Compliance with Written Authority Required procedures |
C15348 | P15348 | CN15348 | Dupilumab | Uncontrolled severe asthma Continuing treatment Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 12 years or older. An adequate response to this biological medicine is defined as: (a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5. All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and, for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following information must be provided at the time of application and must be documented in the patient's medical records: (a) if applicable, details of maintenance oral corticosteroid dose; and (b) a completed Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
C15355 | P15355 | CN15355 | Buprenorphine Buprenorphine with naloxone | Opioid dependence The treatment must be within a framework of medical, social and psychological treatment. A medical practitioner must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15355 |
C15356 | P15356 | CN15356 | Buprenorphine | Opioid dependence Must be treated by a health care professional. The treatment must be within a framework of medical, social and psychological treatment; AND Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15356 |
C15358 | P15358 | CN15358 | Methadone | Opioid dependence The treatment must be within a framework of medical, social and psychological treatment. A medical practitioner must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15358 |
C15362 | P15362 | CN15362 | Tafamidis | Transthyretin amyloid cardiomyopathy First PBS-subsidised prescription for this drug The condition must have documented evidence of transthyretin precursor protein present; AND Patient must have experienced at least one episode of hospitalisation that was a direct result of heart failure; OR Patient must have clinical evidence of heart failure without hospitalisation that required treatment with a diuretic for improvement; AND Patient must have/have had New York Heart Association class I heart failure at the time of commencing this drug; OR Patient must have/have had New York Heart Association class II heart failure at the time of commencing this drug; AND Patient must have an end-diastolic interventricular septal wall thickness of at least 12 mm on imaging; AND Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2. Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Evidence of clinical findings to establish the diagnosis: In this authority application, confirm that there is documented evidence of transthyretin precursor protein through either (1) alone, or, both (2) and (3), from the list below: Confirm the following has been completed: (1) amyloid expert centre histology findings derived via immunohistochemistry or mass spectrometry; OR (2) bone scintigraphy with grade 2-3 finding AND (3) Confirm that there are negative results for monoclonal protein on each of the following three tests: (a) serum immunofixation (also known as protein electrophoresis) (b) urine immunofixation (c) serum free light chains blood test State which of (1) to (3) above has been completed, as well as the: (i) date of the finding, (ii) imaging/pathology report number/code that links the finding to the patient, (iii) name of the amyloid expert centre in this authority application (if applicable). For end-diastolic interventricular septal wall thickness (at least 12 mm), confirm that: (i) imaging (echocardiogram or magnetic resonance imaging) has been undertaken; and (ii) that the imaging report is stored in the patient's medical records. State the date that the imaging was performed and the thickness (in mm) in this authority application. Where this authority application is to transition a patient from non-PBS-subsidised to PBS-subsidised supply (i.e. a 'grandfathered' patient), confirm the following: (i) the patient's heart failure has not worsened to persistent New York Heart Association Class III/IV heart failure while taking this drug. | Compliance with Written Authority Required procedures |
C15363 | P15363 | CN15363 | Melatonin | Insomnia Continuing Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have experienced/maintained a clinically meaningful response (as defined below) to the preceding supply of this drug - document the response improvement in the patient's medical records; AND The treatment must have commenced between the ages of 2 to 17 years inclusive. Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion. Treatment must cease if a patient is unable to achieve a clinically meaningful response on the maximum dose of melatonin specified in the Product Information. Definition: A clinically meaningful response to this drug is defined as at least one of: (i) an increase in total sleep time of at least 45 minutes per night on average from baseline; (ii) a decrease in the time it takes to fall asleep by at least 15 minutes per night on average from baseline. | Compliance with Authority Required procedures |
C15366 | P15366 | CN15366 | Alirocumab | Familial heterozygous hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND Patient must have an LDL cholesterol level in excess of 2.6 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication. Must be treated by a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. The following must be stated at the time of application and documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures |
C15369 | P15369 | CN15369 | Inclisiran | Familial heterozygous hypercholesterolaemia Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2024; AND The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing prior to starting non-PBS-subsidised treatment with this drug for this condition; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6 prior to starting non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease at the time non-PBS-subsidised treatment with this drug for this condition was initiated; OR Patient must have had an LDL cholesterol level in excess of 5 millimoles per litre at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must have developed a clinically important product-related adverse event necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication. Must be treated by a specialist physician; OR Must be treated by a physician who has consulted a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level must have been measured following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events), must be stated at the time of application, documented in the patient's medical records and must have been no more than 8 weeks old at the time non-PBS-subsidised treatment with this drug for this condition was initiated. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin resulted in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must have been treated with the alternative statin (atorvastatin or rosuvastatin) unless there was a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should have occurred after a washout period of at least 4 weeks, or if the creatine kinase (CK) level was elevated, the retrial should not have occurred until CK had returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. The following must be stated at the time of application and documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures |
C15370 | P15370 | CN15370 | Olaparib | Early breast cancer Initial treatment The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND Patient must have received neoadjuvant or adjuvant chemotherapy; AND The treatment must be adjuvant to surgical resection; AND The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND Patient must have received neoadjuvant chemotherapy, and residual invasive cancer is confirmed in the breast and/or resected lymph nodes (pathological complete response was not achieved); OR Patient must have received adjuvant chemotherapy for triple negative breast cancer, and has either: (a) node positive disease is present, (b) a primary tumour greater than 20 mm; OR Patient must have received adjuvant chemotherapy for hormone receptor positive breast cancer, and has at least 4 positive lymph nodes; AND The treatment must not be a PBS-subsidised benefit beyond the following, whichever comes first: (i) a total of 52 weeks of treatment (including any non-PBS-subsidised supply), (ii) disease recurrence. Mark any remaining repeat prescriptions with the word 'cancelled' where (i)/(ii) has occurred; AND The treatment must be commenced within 12 weeks of completing other therapy noting that other therapy can be any of the following therapy: (i) surgery, (ii) radiotherapy, (iii) chemotherapy; AND The treatment must not be in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab. Retain all pathology imaging and investigative test results in the patient's medical records. | Compliance with Authority Required procedures |
C15371 | P15371 | CN15371 | Olaparib | Early breast cancer Continuing treatment Patient must have received PBS-subsidised treatment with this drug as adjuvant therapy for this condition; AND Patient must not have developed disease recurrence while receiving treatment with this drug for this condition; AND The treatment must not be a PBS-subsidised benefit beyond a total of 52 weeks of treatment (including any non-PBS-subsidised supply); AND The treatment must not be in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab. | Compliance with Authority Required procedures |
C15385 | P15385 | CN15385 | Buprenorphine | Opioid dependence Must be treated by a health care professional. The treatment must be within a framework of medical, social and psychological treatment. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15385 |
C15391 | P15391 | CN15391 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Continuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response. | Compliance with Authority Required procedures |
C15395 | P15395 | CN15395 | Evolocumab | Non-familial hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have symptomatic atherosclerotic cardiovascular disease; AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); OR Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; OR Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; OR Patient must have diabetes mellitus with microalbuminuria; OR Patient must have diabetes mellitus and be aged 60 years or more; OR Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication. Must be treated by a specialist physician; OR Must be treated by a physician who has consulted a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. One of the following must be documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. One or more of the following must be documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event: (i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or (ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or (iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or (iv) diabetes mellitus with microalbuminuria; or (v) diabetes mellitus and age 60 years of more; or (vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or (vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures - Streamlined Authority Code 15395 |
C15406 | P15406 | CN15406 | Deucravacitinib | Severe chronic plaque psoriasis Patient must not have achieved adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug; OR Patient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information; OR Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; AND The condition must have caused significant interference with quality of life; AND Patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) apremilast. Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; OR Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar; OR Must be treated by a general practitioner where there is agreement to continue treatment (not initiate treatment) with one of the above practitioner types. Patient must be at least 18 years of age. For patients who do not demonstrate an adequate response to deucravacitinib, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to 'biological medicines' for the treatment of 'severe chronic plaque psoriasis'. This assessment must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 15406 |
C15407 | P15407 | CN15407 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response. | Compliance with Authority Required procedures |
C15408 | P15408 | CN15408 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; OR The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug class for the first time; OR Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity. Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above. | Compliance with Authority Required procedures |
C15409 | P15409 | CN15409 | Alirocumab | Non-familial hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have symptomatic atherosclerotic cardiovascular disease; AND Patient must have an LDL cholesterol level in excess of 2.6 millimoles per litre prior to commencing treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9); AND Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); OR Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; OR Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; OR Patient must have diabetes mellitus with microalbuminuria; OR Patient must have diabetes mellitus and be aged 60 years or more; OR Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication. Must be treated by a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. One or more of the following must be stated at the time of application and documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event: (i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or (ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or (iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or (iv) diabetes mellitus with microalbuminuria; or (v) diabetes mellitus and age 60 years or more; or (vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or (vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures |
C15410 | P15410 | CN15410 | Evolocumab | Familial heterozygous hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication. Must be treated by a specialist physician; OR Must be treated by a physician who has consulted a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. The following must be documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia One of the following must be documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures - Streamlined Authority Code 15410 |
C15414 | P15414 | CN15414 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug class for the first time; OR Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing. | Compliance with Authority Required procedures |
C15416 | P15416 | CN15416 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Continuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response. | Compliance with Authority Required procedures |
C15424 | P15424 | CN15424 | Dupilumab | Uncontrolled severe asthma Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have been receiving regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; OR Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids as outlined in the clinical criteria. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 the same treatment cycle. A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle. The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and (b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (d) Asthma Control Questionnaire (ACQ-5) score; and (e) if applicable, the eosinophil count and date; and (f) if applicable, the IgE result and date. | Compliance with Written Authority Required procedures |
C15425 | P15425 | CN15425 | Dupilumab | Uncontrolled severe asthma Initial treatment - Initial 2 (Change of treatment) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have each of: (i) total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, (ii) past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND Patient must have received regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and (c) if applicable, the eosinophil count and date; and (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (e) if applicable, the IgE result and date; and (f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). | Compliance with Written Authority Required procedures |
C15428 | P15428 | CN15428 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response. | Compliance with Authority Required procedures |
C15430 | P15430 | CN15430 | Inclisiran | Non-familial hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have symptomatic atherosclerotic cardiovascular disease; AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); OR Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; OR Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; OR Patient must have diabetes mellitus with microalbuminuria; OR Patient must have diabetes mellitus and be aged 60 years or more; OR Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication. Must be treated by a specialist physician; OR Must be treated by a physician who has consulted a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. One or more of the following must be stated at the time of application and documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event: (i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or (ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or (iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or (iv) diabetes mellitus with microalbuminuria; or (v) diabetes mellitus and age 60 years or more; or (vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or (vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures |
C15432 | P15432 | CN15432 | Evolocumab | Familial homozygous hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7; AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information. Must be treated by a specialist physician; OR Must be treated by a physician who has consulted a specialist physician. The qualifying LDL cholesterol level following at least 12 consecutive weeks of treatment with a statin (unless treatment with a statin is contraindicated or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. The following must be documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial homozygous hypercholesterolaemia One of the following must be documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures - Streamlined Authority Code 15432 |
C15433 | P15433 | CN15433 | Dupilumab | Uncontrolled severe asthma Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; OR Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; OR Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 the same treatment cycle. A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle. The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and (b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (d) Asthma Control Questionnaire (ACQ-5) score; and (e) if applicable, the eosinophil count and date; and (f) if applicable, the IgE result and date. | Compliance with Written Authority Required procedures |
C15439 | P15439 | CN15439 | Buprenorphine | Opioid dependence Must be treated by a health care professional. The treatment must be within a framework of medical, social and psychological treatment; AND Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15439 |
C15440 | P15440 | CN15440 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; OR The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug class for the first time; OR Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity. Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above. | Compliance with Authority Required procedures |
C15441 | P15441 | CN15441 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug class for the first time; OR Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing. | Compliance with Authority Required procedures |
C15443 | P15443 | C15443 | Inclisiran | Familial heterozygous hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication. Must be treated by a specialist physician; OR Must be treated by a physician who has consulted a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. The following must be stated at the time of application and documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures |
[382] Schedule 5, entry for Aciclovir in the form Tablet 200 mg
insert in alphabetical order in the column headed “Brand”: ARX-ACICLOVIR
[383] Schedule 5, entry for Amlodipine in the form Tablet 5 mg (as besilate)
insert in alphabetical order in the column headed “Brand”: APX-AMLODIPINE
[384] Schedule 5, entry for Amoxicillin with clavulanic acid
substitute:
Amoxicillin with clavulanic acid | GRP-28006 | Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Oral | Augmentin Duo 400
Curam Duo |
Amoxicillin with clavulanic acid | GRP-20135 | Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | AlphaClav Duo
AMCLAVOX DUO 500/125
Amoxycillin/Clavulanic Acid 500/125 APOTEX
APO-AMOXY/CLAV 500/125
APO-Amoxycillin/ Clavulanic Acid 500/125
APX-Amoxicillin/Clavulanic Acid
Augmentin Duo
Curam Duo 500/125 |
Amoxicillin with clavulanic acid | GRP-26768 | Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | AlphaClav Duo Forte
Alphaclav Duo Forte Viatris
AMCLAVOX DUO FORTE 875/125
AmoxyClav generichealth 875/125
APO-AMOXY/CLAV 875/125
APO-Amoxycillin and Clavulanic Acid
APX-Amoxicillin/Clavulanic Acid
Augmentin Duo forte
Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125
Curam Duo Forte 875/125 |
[385] Schedule 5, entry for Aripiprazole in the form Tablet 10 mg
omit from the column headed “Brand”: Aripic Aripiprazole
[386] Schedule 5, entry for Atorvastatin in the form Tablet 10 mg (as calcium)
omit from the column headed “Brand”: Atorvastatin GH
[387] Schedule 5, entry for Atorvastatin in the form Tablet 40 mg (as calcium)
omit from the column headed “Brand”: Atorvastatin GH
[388] Schedule 5, entry for Benzathine benzylpenicillin in the form Powder for injection 1,200,000 units with diluent 5 mL (S19A)
omit from the column headed “Brand”: Benzylpenicillin Benzathine (Brancaster Pharma, UK)
[389] Schedule 5, after entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg
insert:
Bivalirudin | GRP-21165 | Powder for I.V. injection 250 mg (as trifluoroacetate) | Injection | BIVALIRUDIN ARX
Bivalirudin APOTEX |
[390] Schedule 5, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses
insert in alphabetical order in the column headed “Brand”: Bufomix Easyhaler 400/12
[391] Schedule 5, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 16 mg; Tablet containing candesartan cilexetil 32 mg; Tablet containing candesartan cilexetil 4 mg; and Tablet containing candesartan cilexetil 8 mg
omit from the column headed “Brand”: NOUMED CANDESARTAN
[392] Schedule 5, omit entry for Ceftriaxone
[393] Schedule 5, entry for Clindamycin
omit from the column headed “Brand”: Clindamycin BNM
[394] Schedule 5, entry for Desvenlafaxine
substitute:
Desvenlafaxine | GRP-16219 | Tablet (extended release) 100 mg (as succinate) | Oral | Pristiq |
Desvenlafaxine | GRP-16219 | Tablet (modified release) 100 mg | Oral | BTC Desvenlafaxine
Desfax
DESVEN
Desvenlafaxine Sandoz |
Desvenlafaxine | GRP-16219 | Tablet (modified release) 100 mg (as benzoate) | Oral | APO-Desvenlafaxine MR
Desvenlafaxine GH XR |
Desvenlafaxine | GRP-16220 | Tablet (extended release) 50 mg (as succinate) | Oral | Pristiq |
Desvenlafaxine | GRP-16220 | Tablet (modified release) 50 mg | Oral | BTC Desvenlafaxine
Desfax
DESVEN
Desvenlafaxine Sandoz |
Desvenlafaxine | GRP-16220 | Tablet (modified release) 50 mg (as benzoate) | Oral | APO-Desvenlafaxine MR
Desvenlafaxine GH XR |
[395] Schedule 5, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
insert in alphabetical order in the column headed “Brand”: SalplusF DPI 250/50
[396] Schedule 5, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
insert in alphabetical order in the column headed “Brand”: SalplusF DPI 500/50
[397] Schedule 5, entry for Glimepiride in each of the forms: Tablet 1 mg; Tablet 2 mg; Tablet 4 mg; and Tablet 3 mg
insert in alphabetical order in the column headed “Brand”: ARX-GLIMEPIRIDE
[398] Schedule 5, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 mg
insert in alphabetical order in the column headed “Brand”: APO-LEFLUNOMIDE
[399] Schedule 5, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 10 mg
insert in alphabetical order in the column headed “Brand”: ARX-LERCANIDIPINE
[400] Schedule 5, entry for Letrozole
insert in alphabetical order in the column headed “Brand”: ARX-LETROZOLE
[401] Schedule 5, entry for Levetiracetam in each of the forms: Tablet 1 g; and Tablet 250 mg
insert in alphabetical order in the column headed “Brand”: Levetiracetam Viatris
[402] Schedule 5, entry for Medroxyprogesterone in the form Injection containing medroxyprogesterone acetate 150 mg in 1 mL
omit from the column headed “Brand”: Depo-Ralovera
[403] Schedule 5, after entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL [GRP-20890]
insert:
Morphine | GRP-28763 | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL | Oral | Ordine 5 |
Morphine | GRP-28763 | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL (S19A) | Oral | RA-Morph (NZ) |
[404] Schedule 5, entry for Morphine in each of the forms: Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL; and Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (S19A) [GRP-28497]
substitute:
Morphine | GRP-28497 | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL | Oral | Ordine 10 |
Morphine | GRP-28497 | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (RA-Morph)(S19A) | Oral | RA-Morph (NZ) |
Morphine | GRP-28497 | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (S19A) | Oral | Morphini HCl Streuli |
[405] Schedule 5, after entry for Naloxone in the form Nasal spray 1.8 mg (as hydrochloride dihydrate) in 0.1 mL single dose unit, 2 (s19A) [GRP-27818]
insert:
Naltrexone | GRP-19914 | Tablet containing naltrexone hydrochloride 50 mg | Oral | ARX-NALTREXONE
Naltrexone GH |
[406] Schedule 5, after entry for Nifedipine in the form Tablet 60 mg (controlled release) [GRP-19801]
insert:
Niraparib | GRP-28761 | Capsule 100 mg (as tosilate monohydrate) | Oral | Zejula |
Niraparib | GRP-28761 | Tablet 100 mg (as tosilate monohydrate) | Oral | Zejula |
[407] Schedule 5, entry for Octreotide
substitute:
Octreotide | GRP-17613 | Injection (modified release) 10 mg (as acetate), vial and diluent syringe | Injection | Octreotide Depot
Sandostatin LAR |
Octreotide | GRP-17622 | Injection (modified release) 20 mg (as acetate), vial and diluent syringe | Injection | Octreotide Depot
Sandostatin LAR |
Octreotide | GRP-17615 | Injection (modified release) 30 mg (as acetate), vial and diluent syringe | Injection | Octreotide Depot
Sandostatin LAR |
Octreotide | GRP-20282 | Injection 100 micrograms (as acetate) in 1 mL | Injection | Octreotide (SUN)
Octreotide GH
Sandostatin 0.1 |
Octreotide | GRP-20282 | Injection 100 micrograms (as acetate) in 1 mL (S19A) | Injection | Octreotide Acetate Omega (Canada) |
Octreotide | GRP-20060 | Injection 50 micrograms (as acetate) in 1 mL | Injection | Octreotide (SUN)
Octreotide GH
Sandostatin 0.05 |
Octreotide | GRP-20060 | Injection 50 micrograms (as acetate) in 1 mL (S19A) | Injection | Octreotide Acetate Omega (Canada) |
Octreotide | GRP-20085 | Injection 500 micrograms (as acetate) in 1 mL | Injection | Octreotide (SUN)
Octreotide Acetate Omega (Canada)
Octreotide GH
Sandostatin 0.5 |
[408] Schedule 5, entry for Olanzapine in the form Tablet 2.5 mg
insert in alphabetical order in the column headed “Brand”: APO-OLANZAPINE
[409] Schedule 5, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
insert in alphabetical order in the column headed “Brand”: APX-PANTOPRAZOLE
[410] Schedule 5, omit entries for Phenoxymethylpenicillin [GRP-27408]
[411] Schedule 5, entry for Pirfenidone in each of the forms: Tablet 267 mg; and Tablet 801mg
insert in alphabetical order in the column headed “Brand”: Pirfenidone Dr.Reddy's
[412] Schedule 5, entry for Rosuvastatin in each of the forms: Tablet 20 mg (as calcium); and Tablet 40 mg (as calcium)
insert in alphabetical order in the column headed “Brand”: APO-ROSUVASTATIN
[413] Schedule 5, entry for Roxithromycin in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Brand”: Roximycin
[414] Schedule 5, entry for Sevelamer in the form Tablet containing sevelamer carbonate 800 mg
insert in alphabetical order in the column headed “Brand”: ARX-SEVELAMER
[415] Schedule 5, entry for Sitagliptin in each of the forms: Tablet 100 mg; Tablet 25 mg; and Tablet 50 mg
insert in alphabetical order in the column headed “Brand”: Sitagliptin Mylan
[416] Schedule 5, entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride
insert in alphabetical order in the column headed “Brand”: Sitagliptin/Metformin Mylan 50/1000
[417] Schedule 5, entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride
insert in alphabetical order in the column headed “Brand”: Sitagliptin/Metformin Mylan 50/500
[418] Schedule 5, entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride
insert in alphabetical order in the column headed “Brand”: Sitagliptin/Metformin Mylan 50/850
[419] Schedule 5, entry for Teriparatide
substitute:
Teriparatide | GRP-25564 | Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen | Injection | Teriparatide Lupin
Terrosa |
[420] Schedule 5, entry for Topiramate in each of the forms: Tablet 100 mg; Tablet 200 mg; Tablet 25 mg; and Tablet 50 mg
omit from the column headed “Brand”: NOUMED TOPIRAMATE
[421] Schedule 5, entry for Varenicline
substitute:
Varenicline | GRP-27996 | Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack | Oral | Champix
PHARMACOR VARENICLINE
VARENAPIX |
Varenicline | GRP-26245 | Tablet 1 mg (as tartrate) | Oral | Champix
PHARMACOR VARENICLINE
VARENAPIX
Varenicline Viatris |
