Schedule 1—Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
[1] Schedule 1, Part 1, entry for Abiraterone and methylprednisolone
insert as first entry:
| Pack containing 120 tablets abiraterone acetate 125 mg and 30 tablets methylprednisolone 4 mg | Oral | | Yonsa Mpred | RA | MP | C14034 | | 1 | 5 | 1 | | |
[2] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without methionine
(a) omit:
| Oral liquid 87 mL, 30 (HCU cooler 10) | Oral | | HCU cooler 10 | VF | MP NP | C5534 | | 4 | 5 | 1 | | |
(b) omit:
| Oral liquid 130 mL, 30 (HCU cooler 15) | Oral | | HCU cooler 15 | VF | MP NP | C5534 | | 4 | 5 | 1 | | |
[3] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine
omit:
| Sachets containing oral powder 24 g, 30 (MMA/PA gel) | Oral | | MMA/PA gel | VF | MP NP | C5542 C5560 | | 4 | 5 | 1 | | |
[4] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
(a) omit:
| Oral liquid 87 mL, 30 (TYR cooler 10) | Oral | | TYR cooler 10 | VF | MP NP | C5533 | | 4 | 5 | 1 | | |
(b) omit:
| Oral liquid 130 mL, 30 (TYR cooler 15) | Oral | | TYR cooler 15 | VF | MP NP | C5533 | | 4 | 5 | 1 | | |
(c) omit:
| Sachets containing oral powder 25 g, 30 (TYR express 15) | Oral | | TYR express 15 | VF | MP NP | C5533 | | 4 | 5 | 1 | | |
[5] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
omit:
| Oral liquid 87 mL, 30 (MSUD cooler 10) | Oral | | MSUD cooler 10 | VF | MP NP | C5571 | | 4 | 5 | 1 | | |
[6] Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium)
(a) omit:
| | | a | Atorvastatin GH | GQ | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Atorvastatin GH | GQ | MP NP | | P14238 | 60 | 5 | 30 | | |
[7] Schedule 1, Part 1, entry for Betamethasone in the form Cream 200 micrograms (as valerate) per g, 100 g
(a) omit from the column headed “Responsible Person” for the brand “Antroquoril”: OV substitute: AL
(b) omit from the column headed “Responsible Person” for the brand “Celestone‑M”: OQ substitute: AF
[8] Schedule 1, Part 1, entry for Betamethasone in the form Cream 500 micrograms (as dipropionate) per g, 15 g
(a) omit from the column headed “Responsible Person” for the brand “Diprosone” (all instances): OQ substitute (all instances): AF
(b) omit from the column headed “Responsible Person” for the brand “Eleuphrat” (all instances): OV substitute (all instances): AL
[9] Schedule 1, Part 1, entry for Betamethasone in the form Ointment 500 micrograms (as dipropionate) per g, 15 g
(a) omit from the column headed “Responsible Person” for the brand “Diprosone” (all instances): OQ substitute (all instances): AF
(b) omit from the column headed “Responsible Person” for the brand “Eleuphrat” (all instances): OV substitute (all instances): AL
[10] Schedule 1, Part 1, entry for Bisoprolol in the each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg
(a) omit:
| | | a | Bisoprolol Dr.Reddy's | RI | MP NP | C5324 C14251 | P5324 | 28 | 5 | 28 | | |
(b) omit:
| | | a | Bisoprolol Dr.Reddy's | RI | MP NP | C5324 C14251 | P14251 | 56 | 5 | 28 | | |
[11] Schedule 1, Part 1, entry for Cinacalcet in the form Tablet 30 mg (as hydrochloride)
(a) omit:
| | | a | Cinacalcet Mylan | AF | MP NP | C10068 | | 28 | 5 | 28 | | |
(b) omit:
| | | a | Cinacalcet Mylan | AF | MP | C10063 C10067 C10073 | | 56 | 5 | 28 | | C(100) |
[12] Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
(a) omit:
| | | | Clopidogrel GH | GQ | MP NP | | | 28 | 5 | 28 | | |
(b) omit:
| | | | Clopidogrel GH | GQ | MP NP | | P14238 | 56 | 5 | 28 | | |
[13] Schedule 1, Part 1, entry for Cyclophosphamide in the form Powder for injection 500 mg (anhydrous)
omit:
| | | | Endoxan | BX | MP | | | See Note 3 | See Note 3 | 1 | | PB(100) |
[14] Schedule 1, Part 1, entry for Dapagliflozin in the form Tablet 10 mg (as propanediol monohydrate) [Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 5; and Authorised Prescriber: NP; Maximum Quantity: 28; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C12477
(b) insert in numerical order in the column headed “Circumstances”: C14471
(c) omit from the column headed “Circumstances”: C14976
(d) insert in numerical order in the column headed “Circumstances”: C15047 C15051
(e) omit from the column headed “Purposes”: P12477
(f) insert in numerical order in the column headed “Purposes”: P14471 P15047
[15] Schedule 1, Part 1, entry for Dapagliflozin in the form Tablet 10 mg (as propanediol monohydrate) [Authorised Prescriber: MP; Maximum Quantity: 56; Number of Repeats: 5; and Authorised Prescriber: NP; Maximum Quantity: 56; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C12477
(b) insert in numerical order in the column headed “Circumstances”: C14471
(c) omit from the column headed “Circumstances”: C14976
(d) insert in numerical order in the column headed “Circumstances”: C15047 C15051
(e) omit from the column headed “Purposes”: P14976
(f) insert in numerical order in the column headed “Purposes”: P15051
[16] Schedule 1, Part 1, entry for Empagliflozin in the form Tablet 10 mg [Authorised Prescriber: MP; Maximum Quantity: 30; Number of Repeats: 5; and Authorised Prescriber: NP; Maximum Quantity: 30; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C12477
(b) omit from the column headed “Circumstances”: C14976
(c) insert in numerical order in the column headed “Circumstances”:C15047 C15051
(d) omit from the column headed “Purposes”: P12477
(e) insert in numerical order in the column headed “Purposes”: P15047
[17] Schedule 1, Part 1, entry for Empagliflozin in the form Tablet 10 mg [Authorised Prescriber: MP; Maximum Quantity: 60; Number of Repeats: 5; and Authorised Prescriber: NP; Maximum Quantity: 60; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C12477
(b) omit from the column headed “Circumstances”: C14976
(c) insert in numerical order in the column headed “Circumstances”: C15047 C15051
(d) omit from the column headed “Purposes”: P14976
(e) insert in numerical order in the column headed “Purposes”: P15051
[18] Schedule 1, Part 1, entry for Entecavir in the form Tablet 1 mg (as monohydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Entecavir Viatris | AL | MP NP | C5037 C5044 | | 60 | 5 | 30 | | D(100) |
[19] Schedule 1, Part 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Blooms Escitalopram | BG | MP NP | C4690 C4703 C4755 C4756 C4757 | | 28 | 5 | 28 | | |
[20] Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-10 mg
(a) omit:
| | | a | EZESIM 10/10 | RZ | MP NP | C7958 C14269 | P7958 | 30 | 5 | 30 | | |
(b) omit:
| | | a | EZESIM 10/10 | RZ | MP NP | C7958 C14269 | P14269 | 60 | 5 | 30 | | |
[21] Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-20 mg
(a) omit:
| | | a | EZESIM 10/20 | RZ | MP NP | C7958 C14269 | P7958 | 30 | 5 | 30 | | |
(b) omit:
| | | a | EZESIM 10/20 | RZ | MP NP | C7958 C14269 | P14269 | 60 | 5 | 30 | | |
[22] Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-40 mg
(a) omit:
| | | a | EZESIM 10/40 | RZ | MP NP | C7957 C14284 | P7957 | 30 | 5 | 30 | | |
(b) omit:
| | | a | EZESIM 10/40 | RZ | MP NP | C7957 C14284 | P14284 | 60 | 5 | 30 | | |
[23] Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-80 mg
(a) omit:
| | | a | EZESIM 10/80 | RZ | MP NP | C7957 C14284 | P7957 | 30 | 5 | 30 | | |
(b) omit:
| | | a | EZESIM 10/80 | RZ | MP NP | C7957 C14284 | P14284 | 60 | 5 | 30 | | |
[24] Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | BTC Fenofibrate | BG | MP NP | | | 30 | 5 | 30 | | |
[25] Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | BTC Fenofibrate | BG | MP NP | | P14238 | 60 | 5 | 30 | | |
[26] Schedule 1, Part 1, after entry for Hydromorphone in the form Oral solution containing hydromorphone hydrochloride 1mg per mL, 1 mL (S19A)
insert:
| Oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL (S19A) (Pharmascience) | Oral | | pms-HYDROmorphone | DZ | MP NP | C10764 C10770 C10777 C11697 | P10764 P10770 P10777 | 500 | 0 | 500 | | |
| | | | | | PDP | C10859 | | 500 | 0 | 500 | | |
| | | | | | MP NP | C10764 C10770 C10777 C11697 | P11697 | 500 | 1 | 500 | | |
[27] Schedule 1, Part 1, after entry for Ibrutinib in the form Capsule 140 mg [Maximum Quantity: 120; Number of Repeats: 5]
insert:
| Tablet 280 mg | Oral | | Imbruvica | JC | MP | C12495 C12500 C14788 | | 30 | 5 | 30 | | |
| Tablet 420 mg | Oral | | Imbruvica | JC | MP | C12495 C12500 C14788 | | 30 | 5 | 30 | | |
| Tablet 560 mg | Oral | | Imbruvica | JC | MP | C12495 C12500 | | 30 | 5 | 30 | | |
[28] Schedule 1, Part 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 10 mg [Maximum Quantity: 28; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
[29] Schedule 1, Part 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 10 mg [Maximum Quantity: 56; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Lercan | RW | MP NP | | P14238 | 56 | 5 | 28 | | |
[30] Schedule 1, Part 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 20 mg [Maximum Quantity: 28; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
[31] Schedule 1, Part 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 20 mg [Maximum Quantity: 56; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Lercan | RW | MP NP | | P14238 | 56 | 5 | 28 | | |
[32] Schedule 1, Part 1, entry for Levetiracetam in the form Tablet 250 mg
(a) omit:
| | | a | Levecetam 250 | RZ | MP NP | C11116 C14964 | P11116 | 60 | 5 | 60 | | |
(b) omit:
| | | a | Levecetam 250 | RZ | MP NP | C11116 C14964 | P14964 | 120 | 5 | 60 | | |
[33] Schedule 1, Part 1, entry for Levetiracetam in the form Tablet 500 mg
(a) omit:
| | | a | Levecetam 500 | RZ | MP NP | C11116 C14964 | P11116 | 60 | 5 | 60 | | |
(b) omit:
| | | a | Levecetam 500 | RZ | MP NP | C11116 C14964 | P14964 | 120 | 5 | 60 | | |
[34] Schedule 1, Part 1, entry for Levetiracetam in the form Tablet 1 g
(a) omit:
| | | a | Levecetam 1000 | RZ | MP NP | C11116 C14964 | P11116 | 60 | 5 | 60 | | |
(b) omit:
| | | a | Levecetam 1000 | RZ | MP NP | C11116 C14964 | P14964 | 120 | 5 | 60 | | |
[35] Schedule 1, Part 1, entry for Methotrexate in the form Injection 5 mg in 2 mL vial [Maximum Quantity: 5; Number of Repeats: 0]
omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
[36] Schedule 1, Part 1, entry for Methotrexate in each of the forms: Injection 7.5 mg in 0.15 mL pre-filled syringe; Injection 10 mg in 0.2 mL pre-filled syringe; Injection 15 mg in 0.3 mL pre-filled syringe; Injection 20 mg in 0.4 mL pre-filled syringe; and Injection 25 mg in 0.5 mL pre-filled syringe
omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
[37] Schedule 1, Part 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial [Maximum Quantity: 5; Number of Repeats: 5]
omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
[38] Schedule 1, Part 1, entry for Methotrexate in each of the forms: Tablet 2.5 mg; and Tablet 10 mg
omit from the column headed “Authorised Prescriber” (all instances): MP substitute (all instances): MP NP
[39] Schedule 1, Part 1, entry for Mitozantrone in the form Injection 20 mg (as hydrochloride) in 10 mL
omit:
| | | | Onkotrone | BX | MP | | | See Note 3 | See Note 3 | 1 | | D(100) |
[40] Schedule 1, Part 1, entry for Modafinil
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Modafinil Viatris | AL | MP | C10935 C10968 C10970 | | 120 | 5 | 60 | | |
[41] Schedule 1, Part 1, entry for Molnupiravir
omit from the column headed “Circumstances”: C13748 C13759 C13765 C13824 substitute: C15050 C15055 C15056 C15062
[42] Schedule 1, Part 1, after entry for Morphine in the form Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL [Maximum Quantity: 400; Number of Repeats: 1]
insert:
| Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (S19A) | Oral | | Morphini HCl Streuli | DZ | PDP | C10859 | | 200 | 0 | 20 | | |
| | | | | | MP NP | C10764 C10770 C10777 C11697 | P10764 P10770 P10777 | 200 | 0 | 20 | | |
| | | | | | MP NP | C10764 C10770 C10777 C11697 | P11697 | 400 | 1 | 20 | | |
[43] Schedule 1, Part 1, entry for Nirmatrelvir and ritonavir
(a) omit from the column headed “Responsible Person”: HD substitute: PF
(b) omit from the column headed “Circumstances”: C14187
(c) insert in numerical order in the column headed “Circumstances”: C15049
[44] Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg
omit:
| | | a | Oxycodone Mylan | AL | MP NP | C10764 C10771 C10772 | | 20 | 0 | 20 | | |
| | | | | | PDP | C10768 | | 20 | 0 | 20 | | |
[45] Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | BTC Pantoprazole | BG | MP NP | C5444 C5512 C5529 | | 30 | 5 | 30 | | |
[46] Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | BTC Pantoprazole | BG | MP | C8774 C8775 C8776 C8780 C8866 C11310 | P8774 P8775 | 30 | 1 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 C8866 | P8774 P8775 | 30 | 1 | 30 | | |
[47] Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | BTC Pantoprazole | BG | MP | C8774 C8775 C8776 C8780 C8866 C11310 | P8776 P8780 P8866 | 30 | 5 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | 30 | | |
[48] Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | BTC Pantoprazole | BG | MP | C8774 C8775 C8776 C8780 C8866 C11310 | P11310 | 60 | 5 | 30 | | |
[49] Schedule 1, Part 1, entry for Permethrin
omit from the column headed “Responsible Person”: JT substitute: ON
[50] Schedule 1, Part 1, entry for Pramipexole in the form Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms [Maximum Quantity: 30; Number of Repeats: 0]
(a) insert in numerical order in the column headed “Circumstances” for the brand “Simpral”: C5411
(b) insert in the column headed “Purposes” for the brand “Simpral”: P5363
[51] Schedule 1, Part 1, entry for Pramipexole in the form Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms [Maximum Quantity: 30; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Simpral | AF | MP NP | C5363 C5411 | P5411 | 30 | 2 | 30 | | |
[52] Schedule 1, Part 1, entry for Pramipexole in the form Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms [Maximum Quantity: 100; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Simpral | AF | MP NP | C5363 C5411 | P5411 | 100 | 2 | 100 | | |
[53] Schedule 1, Part 1, entry for Pramipexole in the form Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms [Maximum Quantity: 100; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances” for the brand “Simpral”: C5411
(b) insert in the column headed “Purposes” for the brand “Simpral”: P5363
[54] Schedule 1, Part 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Blooms The Chemist Quetiapine | BG | MP NP | C7893 C7916 C7927 | | 60 | 0 | 60 | | |
[55] Schedule 1, Part 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | APX-QUETIAPINE | TX | MP NP | C4246 C5611 C5639 | | 90 | 5 | 90 | | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Blooms The Chemist Quetiapine | BG | MP NP | C4246 C5611 C5639 | | 90 | 5 | 90 | | |
[56] Schedule 1, Part 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Blooms The Chemist Quetiapine | BG | MP NP | C4246 C5611 C5639 | | 60 | 5 | 60 | | |
[57] Schedule 1, Part 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Blooms The Chemist Quetiapine | BG | MP NP | C4246 C5611 C5639 | | 60 | 5 | 60 | | |
[58] Schedule 1, Part 1, entry for Telmisartan in each of the forms: Tablet 40 mg; and Tablet 80 mg
(a) omit:
| | | a | Telmisartan-DRLA | RZ | MP NP | | | 28 | 5 | 28 | | |
(b) omit:
| | | a | Telmisartan-DRLA | RZ | MP NP | | P14238 | 56 | 5 | 28 | | |
[59] Schedule 1, Part 2
insert as first entry:
Amino acid formula with vitamins and minerals without methionine | Oral liquid 87 mL, 30 (HCU cooler 10) | Oral | | HCU cooler 10 | VF | MP NP | C5534 | | 4 | 5 | 1 | | |
| Oral liquid 130 mL, 30 (HCU cooler 15) | Oral | | HCU cooler 15 | VF | MP NP | C5534 | | 4 | 5 | 1 | | |
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine | Sachets containing oral powder 24 g, 30 (MMA/PA gel) | Oral | | MMA/PA gel | VF | MP NP | C5542 C5560 | | 4 | 5 | 1 | | |
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine | Oral liquid 87 mL, 30 (TYR cooler 10) | Oral | | TYR cooler 10 | VF | MP NP | C5533 | | 4 | 5 | 1 | | |
| Oral liquid 130 mL, 30 (TYR cooler 15) | Oral | | TYR cooler 15 | VF | MP NP | C5533 | | 4 | 5 | 1 | | |
| Sachets containing oral powder 25 g, 30 (TYR express 15) | Oral | | TYR express 15 | VF | MP NP | C5533 | | 4 | 5 | 1 | | |
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine | Oral liquid 87 mL, 30 (MSUD cooler 10) | Oral | | MSUD cooler 10 | VF | MP NP | C5571 | | 4 | 5 | 1 | | |
[60] Schedule 1, Part 2, omit entry for Estradiol with dydrogesterone
[61] Schedule 1, Part 2, omit entry for Filgrastim
[62] Schedule 3
omit:
HD | Department of Health | 83 605 426 759 |
[63] Schedule 4, Part 1, entry for Abiraterone and methylprednisolone
insert in numerical order after existing text:
| C14034 | | | Metastatic castration sensitive carcinoma of the prostate
The treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy; AND
Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR
Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
Patient must be undergoing concurrent androgen deprivation therapy. | Compliance with Authority Required procedures |
[64] Schedule 4, Part 1, entry for Dapagliflozin
(a) omit:
| C12477 | P12477 | | Chronic heart failure
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 12477 |
(b) insert after entry for Circumstances Code “C13230”:
| C14471 | P14471 | | Chronic heart failure
Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%; AND
Patient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (e.g. left ventricular hypertrophy); AND
Patient must have documented evidence of at least one of the following: (i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation; (ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug; (iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug; (iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 14471 |
(c) omit:
| C14976 | P14976 | | Chronic heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 14976 |
(d) insert in numerical order after existing text:
| C15047 | P15047 | | Chronic heart failure
Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15047 |
| C15051 | P15051 | | Chronic heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15051 |
[65] Schedule 4, Part 1, entry for Empagliflozin
(a) omit:
| C12477 | P12477 | | Chronic heart failure
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 12477 |
(b) omit:
| C14976 | P14976 | | Chronic heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 14976 |
(c) insert in numerical order after existing text:
| C15047 | P15047 | | Chronic heart failure
Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15047 |
| C15051 | P15051 | | Chronic heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15051 |
[66] Schedule 4, Part 1, entry for Molnupiravir
substitute:
Molnupiravir
| C15050 | | | SARS-CoV-2 infection
The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset; OR
The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic.
Patient must be at least 70 years of age.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.
For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.
Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 15050 |
| C15055 | | | SARS-CoV-2 infection
The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.
For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:
1. The patient is in residential aged care
2. The patient has disability with multiple comorbidities and/or frailty
3. Neurological conditions, including stroke and dementia and demyelinating conditions
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease
5. Heart failure, coronary artery disease, cardiomyopathies
6. Obesity (BMI greater than 30 kg/m2)
7. Diabetes type I or II, requiring medication for glycaemic control
8. Renal impairment (eGFR less than 60mL/min)
9. Cirrhosis
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above
11. Past COVID-19 infection episode resulting in hospitalisation.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.
For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.
Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 15055 |
| C15056 | | | SARS-CoV-2 infection
The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be both: (i) at least 50 years of age, (ii) at high risk.
For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:
1. The patient is in residential aged care,
2. The patient has disability with multiple comorbidities and/or frailty,
3. Neurological conditions, including stroke and dementia and demyelinating conditions,
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,
5. Heart failure, coronary artery disease, cardiomyopathies,
6. Obesity (BMI greater than 30 kg/m2),
7. Diabetes type I or II, requiring medication for glycaemic control,
8. Renal impairment (eGFR less than 60mL/min),
9. Cirrhosis, or
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.
For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.
Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 15056 |
| C15062 | | | SARS-CoV-2 infection
The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be at least 18 years of age.
For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with:
1. Any primary or acquired immunodeficiency including:
a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,
b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),
c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR
2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:
a. Chemotherapy or whole body radiotherapy,
b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,
c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),
d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR
3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR
4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR
5. People with disability with multiple comorbidities and/or frailty.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.
For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.
Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 15062 |
[67] Schedule 4, Part 1, entry for Nirmatrelvir and ritonavir
(a) omit:
| C14187 | | | SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be at high risk of requiring hospitalisation for COVID-19 infection; AND
Patient must be at least 50 years old, but not older than 60 years; OR
Patient must be at least 60 years old, but not older than 70 years.
For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:
1. The patient is in residential aged care
2. The patient has disability with multiple comorbidities and/or frailty
3. Neurological conditions, including stroke and dementia and demyelinating conditions
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease
5. Heart failure, coronary artery disease, cardiomyopathies
6. Obesity (BMI greater than 30 kg/m2)
7. Diabetes type I or II, requiring medication for glycaemic control
8. Renal impairment (eGFR less than 60mL/min)
9. Cirrhosis
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above
11. Past COVID-19 infection episode resulting in hospitalisation.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 14187 |
(b) insert in numerical order after existing text:
| C15049 | | | SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be both: (i) at least 50 years of age, (ii) at high risk.
For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:
1. The patient is in residential aged care,
2. The patient has disability with multiple comorbidities and/or frailty,
3. Neurological conditions, including stroke and dementia and demyelinating conditions,
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,
5. Heart failure, coronary artery disease, cardiomyopathies,
6. Obesity (BMI greater than 30 kg/m2),
7. Diabetes type I or II, requiring medication for glycaemic control,
8. Renal impairment (eGFR less than 60mL/min),
9. Cirrhosis, or
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 15049 |
[68] Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
omit from the column headed “Brand”: Clopidogrel GH
[69] Schedule 5, omit entry for Filgrastim
[70] Schedule 5, after entry for Morphine in the form Oral solution containing morphine sulfate 10 mg per 5 mL in 300 mL bottle, 1 mL (S19A) [GRP-28109]
insert:
| GRP-28497 | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL | Oral | Ordine 10 |
| | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (S19A) | Oral | Morphini HCl Streuli |
