National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 5) (Cth)
PB 43 of 2022
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 5)
National Health Act 1953
________________________________________________________________________
I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 25 May 2022
NIKOLAI TSYGANOV
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
________________________________________________________________________
Name of Instrument
(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 5).
(2)This instrument may also be cited as PB 43 of 2022.
Commencement
(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information | ||
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 June 2022 | 1 June 2022 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
Authority
This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Schedule
Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1 - Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1, Part 1, entry for Adrenaline (epinephrine) in the form I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector
(a)omit:
| a | Adrenaline Jr Mylan | AF | MP NP | C4909 C4947 C8734 | 2 | 0 | 1 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Adrenaline Jr Viatris | AF | MP NP | C4909 C4947 C8734 | 2 | 0 | 1 |
Schedule 1, Part 1, entry for Adrenaline (epinephrine) in the form I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector
(a)omit:
| a | Adrenaline Mylan | AF | MP NP | C4909 C4947 C8734 | 2 | 0 | 1 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Adrenaline Viatris | AF | MP NP | C4909 C4947 C8734 | 2 | 0 | 1 |
Schedule 1, Part 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 10 mg
(a)omit:
| a | Amitriptyline Alphapharm 10 | AL | MP NP | 50 | 2 | 50 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Amitriptyline Viatris 10 | AL | MP NP | 50 | 2 | 50 |
Schedule 1, Part 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 25 mg
(a)omit:
| a | Amitriptyline Alphapharm 25 | AL | MP NP | 50 | 2 | 50 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Amitriptyline Viatris 25 | AL | MP NP | 50 | 2 | 50 |
Schedule 1, Part 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 50 mg
(a)omit:
| a | Amitriptyline Alphapharm 50 | AL | MP NP | 50 | 2 | 50 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Amitriptyline Viatris 50 | AL | MP NP | 50 | 2 | 50 |
Schedule 1, Part 1, after entry for Bortezomib in the form Powder for injection 3.5 mg
insert:
| Solution for injection 2.5 mg in 1 mL | Injection | Bortezomib Ever Pharma | IT | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
| Solution for injection 3.5 mg in 1.4 mL | Injection | Bortezomib Ever Pharma | IT | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
omit:
| a | Candesartan HCT GH 32/25 | GQ | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Celecoxib in the form Capsule 100 mg
(a)omit:
| a | APO-Celecoxib | TX | MP NP | C4907 C4962 | 60 | 3 | 60 |
(b)omit:
| a | Celecoxib BTC | JB | MP NP | C4907 C4962 | 60 | 3 | 60 |
(c)omit:
| a | GenRx Celecoxib | GX | MP NP | C4907 C4962 | 60 | 3 | 60 |
Schedule 1, Part 1, entry for Celecoxib in the form Capsule 200 mg
(a)omit:
| a | APO-Celecoxib | TX | MP NP | C4907 C4962 | 30 | 3 | 30 |
(b)omit:
| a | Celecoxib BTC | JB | MP NP | C4907 C4962 | 30 | 3 | 30 |
(c)omit:
| a | GenRx Celecoxib | GX | MP NP | C4907 C4962 | 30 | 3 | 30 |
Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
omit:
| Clopidogrel APOTEX | GX | MP NP | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Clopidogrel Lupin | GQ | MP NP | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Clopidogrel with aspirin
omit:
| a | CoPlavix | SW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Clozapine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Clozitor | JU | MP | C4998 C5015 C9490 | 200 | 0 | 100 | D(100) |
Schedule 1, Part 1, entry for Doxycycline in the form Tablet 50 mg (as monohydrate)
omit:
| Frakas | RW | MP NP | C4475 C4529 C4539 | 25 | 5 | 25 |
Schedule 1, Part 1, entry for Fosinopril in the form Tablet containing fosinopril sodium 10 mg
omit:
| a | Fosipril 10 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Fosinopril in the form Tablet containing fosinopril sodium 20 mg
omit:
| a | Fosipril 20 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Glimepiride in each of the forms: Tablet 1 mg; Tablet 2 mg; and Tablet 3 mg
omit:
| a | APO-Glimepiride | TX | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Glimepiride in the form Tablet 4 mg
(a)omit:
| a | APO-Glimepiride | TX | MP NP | 30 | 5 | 30 |
(b)omit:
| a | Dimirel | AV | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 2 mg in 1 mL [Maximum Quantity: 5; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Hydromorphone-hameln | HW | MP NP | C10764 C10770 C10777 C11697 | P10764 P10770 P10777 | 5 | 0 | 5 |
Schedule 1, Part 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 2 mg in 1 mL [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Hydromorphone-hameln | HW | MP NP | C10764 C10770 C10777 C11697 | P11697 | 10 | 1 | 5 |
Schedule 1, Part 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 10 mg in 1 mL [Maximum Quantity: 5; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Hydromorphone-hameln-HP | HW | MP NP | C10764 C10770 C10777 C11697 | P10764 P10770 P10777 | 5 | 0 | 5 |
Schedule 1, Part 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 10 mg in 1 mL [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Hydromorphone-hameln-HP | HW | MP NP | C10764 C10770 C10777 C11697 | P11697 | 10 | 1 | 5 |
Schedule 1, Part 1, entry for Hydromorphone
omit:
| Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 200 mL | Dilaudid | MF | MP NP | C10764 C10770 C10777 C11697 | P10764 P10770 P10777 | 1 | 0 | 1 |
| PDP | C10859 | 1 | 0 | 1 | ||||
| MP NP | C10764 C10770 C10777 C11697 | P11697 | 2 | 1 | 1 |
Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 60; Number of Repeats: 2]
insert in numerical order the column headed “Circumstances”: C9204 C9206
Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 60; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C9204 C9206
(b)insert in numerical order in the column headed “Purposes”: P9204 P9206
Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 30; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C9204 C9206
Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 30; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C9204 C9206
(b)insert in numerical order in the column headed “Purposes”: P9204 P9206
Schedule 1, Part 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 150 mg-12.5 mg
omit:
| a | KSART HCT 150/12.5 | RW | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-12.5 mg
omit:
| a | KSART HCT 300/12.5 | RW | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-25 mg
omit:
| a | KSART HCT 300/25 | RW | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Isosorbide mononitrate in the form Tablet 60 mg (sustained release)
omit:
| a | GenRx Isosorbide Mononitrate | GX | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Lacosamide in the form Tablet 50 mg [Maximum Quantity: 14; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Lacoress | LR | MP NP | C8813 | 14 | 1 | 14 |
Schedule 1, Part 1, entry for Lacosamide in the form Tablet 100 mg [Maximum Quantity: 14; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Lacoress | LR | MP NP | C8770 C8813 C8815 | P8813 | 14 | 1 | 14 |
Schedule 1, Part 1, entry for Lacosamide in the form Tablet 100 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 | Lacoress | LR | MP NP | C8770 C8813 C8815 | P8770 P8815 | 56 | 5 | 56 |
Schedule 1, Part 1, entry for Lacosamide in the form Tablet 150 mg [Maximum Quantity: 14; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Lacoress | LR | MP NP | C8770 C8813 C8815 | P8813 | 14 | 1 | 14 |
Schedule 1, Part 1, entry for Lacosamide in the form Tablet 150 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 | Lacoress | LR | MP NP | C8770 C8813 C8815 | P8770 P8815 | 56 | 5 | 56 |
Schedule 1, Part 1, entry for Lacosamide in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Lacoress | LR | MP NP | C8770 C8815 | 56 | 5 | 56 |
Schedule 1, Part 1, entry for Latanoprost with timolol
omit:
| a | Latanoprost/Timolol Sandoz 50/5 | SZ | AO | C5038 | 1 | 5 | 1 |
| MP | C4343 | 1 | 5 | 1 |
Schedule 1, Part 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
omit:
| a | Lercan | RW | MP NP | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Letrozole
omit:
| a | APO-Letrozole | TX | MP NP | C5464 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Metoprolol succinate in the form Tablet 23.75 mg (controlled release)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Topreloc-XL | CR | MP NP | C5324 | 15 | 0 | 15 |
Schedule 1, Part 1, entry for Metoprolol succinate in each of the forms: Tablet 47.5 mg (controlled release); Tablet 95 mg (controlled release); and Tablet 190 mg (controlled release)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Topreloc-XL | CR | MP NP | C5324 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Metronidazole in the form Tablet 200 mg
(a)omit:
| a | Flagyl | SW | PDP | 21 | 0 | 21 |
(b)omit:
| a | Flagyl | SW | MP NP | 21 | 1 | 21 |
Schedule 1, Part 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)
(a)omit:
| a | APO-Montelukast | TX | MP NP | C6666 | 28 | 5 | 28 |
(b)omit:
| a | Respikast 4 | RW | MP NP | C6666 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)
(a)omit:
| a | APO-Montelukast | TX | MP NP | C6674 C7781 | 28 | 5 | 28 |
(b)omit:
| a | Respikast 5 | RW | MP NP | C6674 C7781 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg
(a)omit:
| a | APO-Mycophenolate | TX | MP | 150 | 5 | 50 |
(b)omit:
| a | APO-Mycophenolate | TX | MP | P5554 P5795 P9691 P9693 | 300 CN5554 CN5795 CN9691 CN9693 | 5 CN5554 CN5795 CN9691 CN9693 | 50 | C(100) |
Schedule 1, Part 1, entry for Nitrofurantoin in the form Capsule 50 mg
omit:
| ARX-Nitrofurantoin | XT | MP NP MW | 30 | 1 | 30 |
Schedule 1, Part 1, entry for Nitrofurantoin in the form Capsule 100 mg
omit:
| a | ARX-Nitrofurantoin | XT | MP NP MW | 30 | 1 | 30 |
Schedule 1, Part 1, entry for Norfloxacin
omit:
| a | GenRx Norfloxacin | GX | MP NP | C5744 C5806 | 14 | 1 | 14 |
Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; and Tablet 5 mg
omit:
| a | APO-Olanzapine | TX | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 7.5 mg; and Tablet 10 mg
omit:
| a | APO-Olanzapine | TX | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Oxybutynin in the form Tablet containing oxybutynin hydrochloride 5 mg
(a)omit from the column headed “Schedule Equivalent” for the brand “Ditropan”: a
(b)omit:
| a | Oxybutynin Sandoz | SZ | MP NP | C6241 | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 10 mg (controlled release)
(a)omit:
| a | Novacodone | HX | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 |
(b)omit:
| a | Novacodone | HX | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 |
Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 20 mg (controlled release)
(a)omit:
| a | Novacodone | HX | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 |
(b)omit:
| a | Novacodone | HX | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 |
Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 40 mg (controlled release)
(a)omit:
| a | Novacodone | HX | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 |
(b)omit:
| a | Novacodone | HX | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 |
Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 80 mg (controlled release)
(a)omit:
| a | Novacodone | HX | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 |
(b)omit:
| a | Novacodone | HX | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 |
Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit:
| Perindopril APOTEX | TY | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
omit:
| Perindopril APOTEX | TY | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
omit:
| Perindopril APOTEX | TY | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg
(a)omit:
| a | BTC PREGABALIN | JB | MP NP | C4172 | 56 | 5 | 56 |
(b)omit:
| a | Pregabalin APOTEX | GX | MP NP | C4172 | 56 | 5 | 56 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
(a)omit:
| a | APO-Quetiapine | TX | MP NP | C7893 C7916 C7927 | 60 | 0 | 60 |
(b)omit:
| a | Quetiapine Sandoz | SZ | MP NP | C7893 C7916 C7927 | 60 | 0 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)
omit:
| a | APO-Quetiapine XR | TX | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
(a)omit:
| a | APO-Quetiapine | TX | MP NP | C4246 C5611 C5639 | 90 | 5 | 90 |
(b)omit:
| a | Quetiapine Sandoz | SZ | MP NP | C4246 C5611 C5639 | 90 | 5 | 90 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 200 mg (as fumarate)
omit:
| a | APO-Quetiapine XR | TX | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
(a)omit:
| a | APO-Quetiapine | TX | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
(b)omit:
| a | Quetiapine Sandoz | SZ | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)
omit:
| a | APO-Quetiapine XR | TX | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
(a)omit:
| a | APO-Quetiapine | TX | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
(b)omit:
| a | Quetiapine Sandoz | SZ | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)
omit:
| a | APO-Quetiapine XR | TX | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 21; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C11458 C11459
(b)omit from the column headed “Circumstances”: C11506
(c)omit from the column headed “Purposes”: P11506
Schedule 1, Part 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 42; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C11458 C11459
(b)omit from the column headed “Circumstances”: C11506
(c)omit from the column headed “Purposes”: P11459
Schedule 1, Part 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 63; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C11458 C11459
(b)omit from the column headed “Circumstances”: C11506
(c)omit from the column headed “Purposes”: P11458
Schedule 1, Part 1, entry for Rituximab
substitute:
| Rituximab | Solution for I.V. infusion 100 mg in 10 mL | Injection | a | Ruxience | PF | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
| a | Riximyo | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | D(100) | |||
| a | Truxima | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | D(100) | |||
| Ruxience | PF | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 1 | D(100) | |||||
| Riximyo | SZ | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 2 | D(100) | |||||
| Truxima | EW | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 2 | D(100) | |||||
| Solution for I.V. infusion 500 mg in 50 mL | Injection | a | Riximyo | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| a | Ruxience | PF | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |||
| a | Truxima | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |||
| Riximyo | SZ | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 1 | D(100) | |||||
| Ruxience | PF | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 1 | D(100) | |||||
| Truxima | EW | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Rosuvastatin in each of the forms: Tablet 5 mg (as calcium); Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); and Tablet 40 mg (as calcium)
(a)omit:
| a | BTC Rosuvastatin | JB | MP NP | 30 | 5 | 30 |
(b)omit:
| a | BTC Rosuvastatin | JB | MP | P7598 | 30 | 11 | 30 |
Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C10489
(b)omit from the column headed “Circumstances”: C11432
(c)insert in numerical order in the column headed “Circumstances”: C12392
(d)omit from the column headed “Purposes”: P10489
(e)insert in numerical order in the column headed “Purposes”: P12392
Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C10489
(b)omit from the column headed “Circumstances”: C11432
(c)insert in numerical order in the column headed “Circumstances”: C12392
Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C10489
(b)omit from the column headed “Circumstances”: C11432
(c)insert in numerical order in the column headed “Circumstances”: C12392
(d)omit from the column headed “Purposes”: P11432
Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C10489
(b)omit from the column headed “Circumstances”: C11432
(c)insert in numerical order in the column headed “Circumstances”: C12392
Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C10489
(b)omit from the column headed “Circumstances”: C11432
(c)insert in numerical order in the column headed “Circumstances”: C12392
Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C10489
(b)omit from the column headed “Circumstances”: C11432
(c)insert in numerical order in the column headed “Circumstances”: C12392
Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 5; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C10489
(b)omit from the column headed “Circumstances”: C11432
(c)insert in numerical order in the column headed “Circumstances”: C12392
Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 8; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C10489
(b)omit from the column headed “Circumstances”: C11432
(c)insert in numerical order in the column headed “Circumstances”: C12392
Schedule 1, Part 1, entry for Spironolactone in the form Tablet 25 mg
(a)omit:
| a | Spironolactone Mylan 25 | AL | MP NP | 100 | 5 | 100 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Spironolactone Viatris 25 | AL | MP NP | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Spironolactone in the form Tablet 100 mg
(a)omit:
| a | Spironolactone Mylan 100 | AL | MP NP | 100 | 5 | 100 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Spironolactone Viatris 100 | AL | MP NP | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Venetoclax in the form Tablet 10 mg
substitute:
| Tablet 10 mg | Oral | Venclexta | VE | MP | C10995 | 14 | 0 | 2 |
| MP | C10995 | 14 | 0 | 14 |
Schedule 1, Part 1, entry for Voriconazole in the form Tablet 50 mg
(a)omit:
| a | Voriconazole APO | GX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4685 | 56 | 0 | 56 |
| a | Voriconazole APOTEX | TX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4685 | 56 | 0 | 56 |
(b)omit:
| a | Voriconazole APO | GX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4683 P5692 P5725 P5748 | 56 | 2 | 56 |
| a | Voriconazole APOTEX | TX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4683 P5692 P5725 P5748 | 56 | 2 | 56 |
Schedule 1, Part 1, entry for Voriconazole in the form Tablet 200 mg
(a)omit:
| a | Voriconazole APO | GX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4685 | 56 | 0 | 56 |
| a | Voriconazole APOTEX | TX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4685 | 56 | 0 | 56 |
(b)omit:
| a | Voriconazole APO | GX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4683 P5692 P5725 P5748 | 56 | 2 | 56 |
| a | Voriconazole APOTEX | TX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4683 P5692 P5725 P5748 | 56 | 2 | 56 |
Schedule 1, Part 1, entry for Zonisamide in each of the forms: Capsule 25 mg; and Capsule 50 mg
(a)omit:
| a | APO-Zonisamide | TX | MP NP | C4928 | 56 | 5 | 56 |
(b)omit from the column headed “Schedule Equivalent” for the brand “Zonegran”: a
Schedule 1, Part 1, entry for Zonisamide in the form Capsule 100 mg
(a)omit:
| a | APO-Zonisamide | TX | MP NP | C4928 | 112 | 5 | 56 |
(b)omit from the column headed “Schedule Equivalent” for the brand “Zonegran”: a
Schedule 1, Part 2, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
omit:
| Clopidogrel APOTEX | GX | MP NP | C4165 C4166 | 28 | 5 | 28 |
Schedule 1, Part 2, omit entry for Desmopressin
Schedule 1, Part 2, omit entry for Teriparatide
Schedule 3, after details relevant for Responsible Person code HT
insert:
| HW | HAMELN PHARMA PTY. LTD. | 69 638 348 580 |
Schedule 4, Part 1, entry for Ribociclib
(a)omit:
| C11458 | P11458 | Locally advanced or metastatic breast cancer Transitioning from non-PBS to PBS-subsidised supply - 'Grandfather' treatment Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 April 2021; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must have been untreated with each of: (i) abemaciclib, (ii) palbociclib, (iii) ribociclib, at the time non-PBS supply was initiated; OR Patient must have developed an intolerance to abemaciclib or palbociclib of a severity necessitating permanent treatment withdrawal; AND The condition must be hormone receptor positive; AND The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND The condition must be inoperable; AND Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time of non-PBS supply was initiated; AND The treatment must be in combination with one of: (i) anastrozole, (ii) letrozole, (iii) fulvestrant, where the patient had never been treated with endocrine therapy for advanced/metastatic disease at the time non-PBS supply was initiated; OR The treatment must be in combination with fulvestrant only, where at the time non-PBS supply was initiated, the patient had recurrent/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease; AND The treatment must not be in combination with abemaciclib or palbociclib. Patient must not be premenopausal. | Compliance with Authority Required procedures |
| C11459 | P11459 | Locally advanced or metastatic breast cancer Transitioning from non-PBS to PBS-subsidised supply - 'Grandfather' treatment Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 April 2021; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must have been untreated with each of: (i) abemaciclib, (ii) palbociclib, (iii) ribociclib, at the time non-PBS supply was initiated; OR Patient must have developed an intolerance to abemaciclib or palbociclib of a severity necessitating permanent treatment withdrawal; AND The condition must be hormone receptor positive; AND The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND The condition must be inoperable; AND Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time of non-PBS supply was initiated; AND The treatment must be in combination with one of: (i) anastrozole, (ii) letrozole, (iii) fulvestrant, where the patient had never been treated with endocrine therapy for advanced/metastatic disease at the time non-PBS supply was initiated; OR The treatment must be in combination with fulvestrant only, where at the time non-PBS supply was initiated, the patient had recurrent/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease; AND The treatment must not be in combination with abemaciclib or palbociclib; AND Patient must require dosage reduction requiring a pack of 42 tablets. Patient must not be premenopausal. | Compliance with Authority Required procedures |
(b)omit:
| C11506 | P11506 | Locally advanced or metastatic breast cancer Transitioning from non-PBS to PBS-subsidised supply - 'Grandfather' treatment Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 April 2021; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must have been untreated with each of: (i) abemaciclib, (ii) palbociclib, (iii) ribociclib, at the time non-PBS supply was initiated; OR Patient must have developed an intolerance to abemaciclib or palbociclib of a severity necessitating permanent treatment withdrawal; AND The condition must be hormone receptor positive; AND The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND The condition must be inoperable; AND Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time of non-PBS supply was initiated; AND The treatment must be in combination with one of: (i) anastrozole, (ii) letrozole, (iii) fulvestrant, where the patient had never been treated with endocrine therapy for advanced/metastatic disease at the time non-PBS supply was initiated; OR The treatment must be in combination with fulvestrant only, where at the time non-PBS supply was initiated, the patient had recurrent/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease; AND The treatment must not be in combination with abemaciclib or palbociclib; AND Patient must require dosage reduction requiring a pack of 21 tablets. Patient must not be premenopausal. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Secukinumab
(a)omit:
| C10489 | P10489 | Non-radiographic axial spondyloarthritis Continuing treatment or Grandfather patient - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Continuing treatment restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the continuing treatment restriction or the grandfather restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. | Compliance with Authority Required procedures |
(b)omit:
| C11432 | P11432 | Non-radiographic axial spondyloarthritis Grandfather treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this indication prior to 1 April 2021; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that was relieved by exercise but not rest, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis prior to commencing non-PBS-subsidised treatment with this biological medicine; AND The condition must have been diagnosed as non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria, prior to having commenced non-PBS-subsidised treatment with this biological medicine; AND The condition must have been sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI) prior to commencing non-PBS-subsidised treatment with this biological medicine; AND The condition must have had presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent) prior to commencing non-PBS-subsidised treatment with this biological medicine; AND The condition must have had BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium) prior to commencing non-PBS-subsidised treatment with this biological medicine; AND The treatment must not exceed a maximum of 24 weeks with this drug under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response to NSAIDs and must have been demonstrated prior to initiation of non-PBS subsidised treatment with this biological medicine for this condition: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The BASDAI score and CRP level must have been determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must have been no more than 1 month old at the time of initiating non-PBS subsidised treatment with this biological medicine for this condition. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. A Grandfathered 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. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); 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). The baseline BASDAI score and CRP level must also be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C12392 | P12392 | Non-radiographic axial spondyloarthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Somatropin
omit entry for Circumstances Code “C12769” and substitute:
| C12769 | Growth retardation secondary to an intracranial lesion, or cranial irradiation Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have had an intracranial lesion which is under appropriate observation and management; OR Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND 4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR (b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND 6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Teriparatide
(a)omit:
| C11464 | Severe established osteoporosis Initial treatment Patient must be at very high risk of fracture; AND Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND Patient must have had 2 or more fractures due to minimal trauma; AND Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a lifetime maximum of 18 months therapy; AND Patient must not have received treatment with romosozumab; OR Patient must have developed intolerance to romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy. Must be treated by a specialist; OR Must be treated by a consultant physician. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated. If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated. Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum. Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application. | Compliance with Authority Required procedures |
| C11486 | Severe established osteoporosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a lifetime maximum of 18 months therapy. Must be treated by a specialist; OR Must be treated by a consultant physician. | Compliance with Authority Required procedures |
(b)omit entry for Circumstances Code “C12270” and substitute:
| C12270 | Severe established osteoporosis Continuing treatment Patient must have previously been issued with an authority prescription for this drug; AND The treatment must not exceed a lifetime maximum of 18 months therapy. Must be treated by a specialist; OR Must be treated by a consultant physician. | Compliance with Authority Required procedures |
Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-17110]
omit from the column headed “Brand”: Clopidogrel APOTEX
Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-17110]
insert in alphabetical order in the column headed “Brand”: Clopidogrel Lupin
Schedule 5, entry for Doxycyclinein the form Tablet 50 mg (as monohydrate) [GRP-15635]
omit from the column headed “Brand”: Frakas
Schedule 5, entry for Imatinib
(a) omit:
| GRP-21076 | Capsule 100 mg (as mesilate) | Oral | CIPLA IMATINIB ADULT IMATINIB-DRLA Imatinib GH Imatinib-APOTEX |
| Tablet 100 mg (as mesilate) | Oral | Glivec IMATINIB RBX Imatinib-Teva |
(b) omit:
| GRP-21080 | Capsule 400 mg (as mesilate) | Oral | CIPLA IMATINIB ADULT IMATINIB-DRLA Imatinib GH Imatinib-APOTEX |
| Tablet 400 mg (as mesilate) | Oral | Glivec IMATINIB RBX Imatinib-Teva |
Schedule 5, entry for Nitrofurantoinin the form Capsule 50 mg [GRP-25565]
omit from the column headed “Brand”: ARX-Nitrofurantoin
Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]
omit from the column headed “Brand”: Perindopril APOTEX
Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]
omit from the column headed “Brand”: Perindopril APOTEX
Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [GRP-15965]
omit from the column headed “Brand”: Perindopril APOTEX
Schedule 5, omit entry for Teriparatide
0
0
0