National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 10) (Cth)
PB 109 of 2021
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 10)
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 28 October 2021
NIKOLAI TSYGANOV
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health
________________________________________________________________________
Name of Instrument
(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 10).
(2)This instrument may also be cited as PB 109 of 2021.
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 November 2021 1 November 2021
Note: This table relates only to the provisions of this instrument as originally made.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Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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)
Section 4 Definitions
omit:
prescriber code means any of the following codes identifying the kind of person mentioned for the code:
(a) MP—medical practitioner;
(b) PDP—participating dental practitioner;
(c) AO—authorised optometrist;
(d) MW—authorised midwife;
(e) NP—authorised nurse practitioner;
Schedule 1, Part 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose autoinjector [Maximum Quantity: 4; Number of
Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12378 C12385
Schedule 1, Part 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose autoinjector [Maximum Quantity: 4; Number of
Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12378 C12385
(b)insert in numerical order in the column headed “Purposes”: P12378 P12385
Schedule 1, Part 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12378 C12385
Schedule 1, Part 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12378 C12385
(b)insert in numerical order in the column headed “Purposes”: P12378 P12385
Schedule 1, Part 1, entry for Abemaciclib in each of the forms: Tablet 50 mg; Tablet 100 mg; and Tablet 150 mg
omit from the column headed “Circumstances”: C10019 C10032 substitute: C12348 C12367 C12380
Schedule 1, Part 1, entry for Abiraterone in each of the forms: Tablet containing abiraterone acetate 250 mg; and Tablet containing abiraterone acetate 500 mg
omit from the column headed “Circumstances”: C12173 substitute: C12352
Schedule 1, Part 1, entry for Acalabrutinib
omit from the column headed “Circumstances”: C10669
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 2; Pack Quantity: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 2; Pack Quantity: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5; Pack Quantity: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5; Pack Quantity: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 6; Number of Repeats: 0; Pack Quantity: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 6; Number of Repeats: 0; Pack Quantity: 6]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 6; Number of Repeats: 0; Pack Quantity: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 6; Number of Repeats: 0; Pack Quantity: 6]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only code: Nil]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only code: Nil]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only code: Nil]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only code: Nil]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 4; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 4; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 4; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 4; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 4; Number of Repeats: 5]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 4; Number of Repeats: 5]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 4; Number of Repeats: 5]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 4; Number of Repeats: 5]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 6; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 6; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 6; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 6; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 4]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only code: Nil]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only code: Nil]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only code: Nil]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only code: Nil]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
(b)insert in numerical order in the column headed “Purposes”: P12354 P12364 P12366 P12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 6; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 6; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 6; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 6; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12354 C12364 C12366 C12391
Schedule 1, Part 1, entry for Aprepitant
(a)insert in the column headed “Schedule Equivalent” for the existing brand: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APREPITANT SCP | XC | MP NP | C4211 C4215 C6370 C6444 | 1 | 5 | 1 |
| MP | C4216 C4223 C6383 C6464 | 1 | 5 | 1 | C(100) |
Schedule 1, Part 1, entry for Azacitidine
(a)omit from the column headed “Responsible Person” for the brand “Celazadine”: JU substitute: CJ
(b)omit:
| a | Vidaza | CJ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Azathioprine in the form Tablet 50 mg
omit from the column headed “Responsible Person” for the brand “Imazan”: ER substitute: ZS
Schedule 1, Part 1, entry for Baricitinib in the form Tablet 2 mg [Maximum Quantity: 28; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12366
Schedule 1, Part 1, entry for Baricitinib in the form Tablet 2 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12366
(b)insert in numerical order in the column headed “Purposes”: P12354 P12366
Schedule 1, Part 1, entry for Baricitinib in the form Tablet 4 mg [Maximum Quantity: 28; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12366
Schedule 1, Part 1, entry for Baricitinib in the form Tablet 4 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12366
(b)insert in numerical order in the column headed “Purposes”: P12354 P12366
Schedule 1, Part 1, entry for Beclometasone with formoterol and glycopyrronium
omit from the column headed “Circumstances”: C10167 substitute: C12349
Schedule 1, Part 1, entry for Bicalutamide
omit from the column headed “Responsible Person” for the brand “Bicalox”: ER substitute: ZS
Schedule 1, Part 1, entry for Bivalirudin
(a)omit:
| a | Angiomax | XM | MP | C4919 | 1 | 0 | 1 |
(b)omit from the column headed “Schedule Equivalent” for the brand “Bivalirudin APOTEX”: a
Schedule 1, Part 1, after entry for Bortezomib in the form Powder for injection 1 mg
insert:
| Powder for injection 2.5 mg | Injection | Bortezomib Juno | JU | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Botulinum toxin type A purified neurotoxin complex
omit from the column headed “Circumstances”: C10298
Schedule 1, Part 1, after entry for Budesonide with formoterol in the form Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses
insert:
| Budesonide with glycopyrronium and formoterol | Pressurised inhalation containing budesonide 160 micrograms with glycopyrronium 7.2 micrograms and formoterol fumarate dihydrate 5 micrograms per dose, 120 doses | Inhalation by mouth | Breztri Aerosphere | AP | MP NP | C12349 | 1 | 5 | 1 |
Schedule 1, Part 1, entry for Calcipotriol with betamethasone
omit:
| Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g | Application | Daivobet 50/500 gel | LO | MP NP | C7947 | 1 | 1 | 1 |
Schedule 1, Part 1, entry for Calcitriol
omit from the column headed “Responsible Person” for the brand “Calciprox”: ER substitute: ZS
Schedule 1, Part 1, entry for Carvedilol in the form Tablet 3.125 mg
omit from the column headed “Responsible Person” for the brand “Volirop 3.125”: DO substitute: ZS
Schedule 1, Part 1, entry for Carvedilol in the form Tablet 6.25 mg
omit from the column headed “Responsible Person” for the brand “Volirop 6.25”: DO substitute: ZS
Schedule 1, Part 1, entry for Carvedilol in the form Tablet 12.5 mg
omit from the column headed “Responsible Person” for the brand “Volirop 12.5”: DO substitute: ZS
Schedule 1, Part 1, entry for Carvedilol in the form Tablet 25 mg
omit from the column headed “Responsible Person” for the brand “Volirop 25”: DO substitute: ZS
Schedule 1, Part 1, entry for Certolizumab pegol
substitute:
| Certolizumab pegol | Injection 200 mg in 1 mL single use pre-filled syringe | Injection | Cimzia | UC | MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P10459 P12392 | 2 | 0 | 2 |
| MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P8706 P9185 P9625 | 2 | 2 | 2 | |||||
| MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P12393 | 2 | 4 | 2 | |||||
| MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P8627 P8679 P9063 P9105 P9430 P9431 P10431 P12366 | 2 | 5 | 2 | |||||
| MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P8626 P9073 P9074 P9183 P9442 P9537 P9610 P10513 P11386 P11430 P11686 P11748 P12354 | 6 | 0 | 2 | |||||
| Solution for injection 200 mg in 1 mL pre-filled pen | Injection | Cimzia | UC | MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P10459 P12392 | 2 | 0 | 2 | |
| MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P8706 P9185 P9625 | 2 | 2 | 2 | |||||
| MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P12393 | 2 | 4 | 2 | |||||
| MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P8627 P8679 P9063 P9105 P9430 P9431 P10431 P12366 | 2 | 5 | 2 | |||||
| MP | C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12354 C12366 C12392 C12393 | P8626 P9073 P9074 P9183 P9442 P9537 P9610 P10513 P11386 P11430 P11686 P11748 P12354 | 6 | 0 | 2 |
Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
omit:
| a | Cyprostat-100 | SY | MP | 50 | 5 | 50 |
Schedule 1, Part 1, entry for Daratumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 400 mg in 20 mL
(a)omit from the column headed “Circumstances”: C11142
(b)insert in numerical order in the column headed “Circumstances”: C12350
(c)omit from the column headed “Section 100/ Prescriber Bag only”: D(100) substitute: PB(100)
Schedule 1, Part 1, after entry for Daratumumab in the form Solution concentrate for I.V. infusion 400 mg in 20 mL
insert:
| Solution for subcutaneous injection containing daratumumab 1800 mg in 15 mL | Injection | Darzalex | JC | MP | C11075 C11076 C12350 C12369 | P11076 | 1 | 4 | 1 |
| MP | C11075 C11076 C12350 C12369 | P11075 | 1 | 5 | 1 | ||||
| MP | C11075 C11076 C12350 C12369 | P12369 | 1 | 7 | 1 | ||||
| MP | C11075 C11076 C12350 C12369 | P12350 | 1 | 8 | 1 |
Schedule 1, Part 1, after entry for Darbepoetin alfa in the form Injection 150 micrograms in 0.3 mL pre-filled syringe
insert:
| Darolutamide | Tablet 300 mg | Oral | Nubeqa | BN | MP | C12398 | 112 | 5 | 112 |
Schedule 1, Part 1, entry for Electrolyte replacement, oral
substitute:
| Electrolyte replacement, oral | Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 | Oral | O.R.S. | AF | MP NP | C5889 | 1 | 0 | 1 |
| restore O.R.S. | EA | MP | C6786 | 30 | 0 | 1 |
Schedule 1, Part 1, entry for Entrectinib
omit from the column headed “Circumstances”: C10672
Schedule 1, Part 1, entry for Enzalutamide
omit from the column headed “Circumstances”: C12216 substitute: C12371
Schedule 1, Part 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
omit from the column headed “Responsible Person” for the brand “Cilopam-S”: ER substitute: ZS
Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12359 C12366 C12389
Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12359 C12366 C12389
(b)insert in numerical order in the column headed “Purposes”: P12354 P12359 P12366 P12389
Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12366
Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12359 C12366 C12389
Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12366
(b)insert in numerical order in the column headed “Purposes”: P12354 P12366
Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12359 C12366 C12389
(b)insert in numerical order in the column headed “Purposes”: P12354 P12359 P12366 P12389
Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12366
Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum
Quantity: 1; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12359 C12366 C12389
Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12366
(b)insert in numerical order in the column headed “Purposes”: P12354 P12366
Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum
Quantity: 1; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12359 C12366 C12389
(b)insert in numerical order in the column headed “Purposes”: P12354 P12359 P12366 P12389
Schedule 1, Part 1, entry for Evolocumab in the form Injection 140 mg in 1 mL single use pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C10358 C10370
(b)omit from the column headed “Circumstances”: C10389
(c)omit from the column headed “Purposes”: P10358 P10389
Schedule 1, Part 1, entry for Evolocumab in the form Injection 140 mg in 1 mL single use pre-filled pen [Maximum Quantity: 3; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C10358 C10370
(b)omit from the column headed “Circumstances”: C10389
(c)omit from the column headed “Purposes”: P10370
Schedule 1, Part 1, entry for Evolocumab in the form Injection 420 mg in 3.5 mL single use pre-filled cartridge
(a)omit from the column headed “Circumstances”: C10358 C10370
(b)omit from the column headed “Circumstances”: C10389
Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | EZESIM 10/10 | RZ | MP NP | C7958 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | EZESIM 10/20 | RZ | MP NP | C7958 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | EZESIM 10/40 | RZ | MP NP | C7957 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-80 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | EZESIM 10/80 | RZ | MP NP | C7957 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Fluticasone furoate with umeclidinium and vilanterol
omit from the column headed “Circumstances”: C10167 substitute: C12349
Schedule 1, Part 1, entry for Furosemide in the form Tablet 40 mg
omit from the column headed “Responsible Person” for the brand “Frusax”: ER substitute: ZS
Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12366
Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12366
(b)insert in numerical order in the column headed “Purposes”: P12354 P12366
Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12366
Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12366
(b)insert in numerical order in the column headed “Purposes”: P12354 P12366
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: Imatinib-APOTEX; Maximum Quantity: 60; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C9238
(b)insert in numerical order in the column headed “Circumstances”: C9278
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: IMATINIB-DRLA; Maximum Quantity: 60; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9208 P9319
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: Imatinib-APOTEX; Maximum Quantity: 60; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C9238
(b)insert in numerical order in the column headed “Circumstances”: C9278
(c)insert in numerical order in the column headed “Purposes”: P9238
(d)insert in numerical order in the column headed “Purposes”: P9278
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: IMATINIB-DRLA; Maximum Quantity: 60; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9238
(f)insert in numerical order in the column headed “Purposes”: P9278
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: Imatinib-APOTEX; Maximum Quantity: 30; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C9238
(b)insert in numerical order in the column headed “Circumstances”: C9278
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: IMATINIB-DRLA;Maximum Quantity: 30; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9208 P9319
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: Imatinib-APOTEX; Maximum Quantity: 30; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C9238
(b)insert in numerical order in the column headed “Circumstances”: C9278
(c)insert in numerical order in the column headed “Purposes”: P9238
(d)insert in numerical order in the column headed “Purposes”: P9278
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: IMATINIB-DRLA; Maximum Quantity: 30; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9238
(f)insert in numerical order in the column headed “Purposes”: P9278
Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 60; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9208 P9319
Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 60; Number of
Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C9204 C9206
(b)insert in numerical order in the column headed “Circumstances”: C9208
(c)insert in numerical order in the column headed “Circumstances”: C9238
(d)insert in numerical order in the column headed “Circumstances”: C9278
(e)insert in numerical order in the column headed “Circumstances”: C9319
(f)insert in numerical order in the column headed “Purposes”: P9208 P9319
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”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9238
(f)insert in numerical order in the column headed “Purposes”: P9278
Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imatinib-Teva; 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 “Circumstances”: C9208
(c)insert in numerical order in the column headed “Circumstances”: C9238
(d)insert in numerical order in the column headed “Circumstances”: C9278
(e)insert in numerical order in the column headed “Circumstances”: C9319
(f)insert in numerical order in the column headed “Purposes”: P9204 P9206
(g)insert in numerical order in the column headed “Purposes”: P9238
(h)insert in numerical order in the column headed “Purposes”: P9278
Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 30; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9208 P9319
Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 30; Number of
Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C9204 C9206
(b)insert in numerical order in the column headed “Circumstances”: C9208
(c)insert in numerical order in the column headed “Circumstances”: C9238
(d)insert in numerical order in the column headed “Circumstances”: C9278
(e)insert in numerical order in the column headed “Circumstances”: C9319
(f)insert in numerical order in the column headed “Purposes”: P9208 P9319
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”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9238
(f)insert in numerical order in the column headed “Purposes”: P9278
Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imatinib-Teva; 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 “Circumstances”: C9208
(c)insert in numerical order on the column headed “Circumstances”: C9238
(d)insert in numerical order in the column headed “Circumstances”: C9278
(e)insert in numerical order in the column headed “Circumstances”: C9319
(f)insert in numerical order in the column headed “Purposes”: P9204 P9206
(g)insert in numerical order in the column headed “Purposes”: P9238
(h)insert in numerical order in the column headed “Purposes”: P9278
Schedule 1, Part 1, entry for IncobotulinumtoxinA
omit from the column headed “Circumstances”: C10594
Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of
Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C12363 C12378 C12390
(b)insert in numerical order in the column headed “Purposes”: P12363
Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of
Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12363 C12378 C12390
Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of
Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C12363 C12378 C12390
(b)insert in numerical order in the column headed “Purposes”: P12390
Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of
Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12363 C12378 C12390
(b)insert in numerical order in the column headed “Purposes”: P12378
Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C12363 C12378 C12390
(b)insert in numerical order in the column headed “Purposes”: P12363
Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12363 C12378 C12390
Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C12363 C12378 C12390
(b)insert in numerical order in the column headed “Purposes”: P12390
Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12363 C12378 C12390
(b)insert in numerical order in the column headed “Purposes”: P12378
Schedule 1, Part 1, entry for Interferon gamma-1b
omit from the column headed “Responsible Person” for the brand “Imukin”: EU substitute: LM
Schedule 1, Part 1, entry for Isotretinoin in each of the forms: Capsule 10 mg; and Capsule 20 mg
omit from the column headed “Responsible Person” for the brand “Dermatane”: ER substitute: ZS
Schedule 1, Part 1, entry for Isotretinoin in the form Capsule 40 mg
omit from the column headed “Responsible Person” for the brand “Dermatane”: ER substitute: ZS
Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 25 mg
omit from the column headed “Responsible Person” for the brand “Reedos 25”: DO substitute: ZS
Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 50 mg
omit from the column headed “Responsible Person” for the brand “Reedos 50”: DO substitute: ZS
Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 100 mg
omit from the column headed “Responsible Person” for the brand “Reedos 100”: DO substitute: ZS
Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 200 mg
omit from the column headed “Responsible Person” for the brand “Reedos 200”: DO substitute: ZS
Schedule 1, Part 1, entry for Letrozole
omit from the column headed “Responsible Person” for the brand “Gynotril”: ER substitute: ZS
Schedule 1, Part 1, entry for Leuprorelin in the form I.M. injection (3 month modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe
(a)omit from the column headed “Circumstances”: C6422
(b)omit from the column headed “Circumstances”: C6426
(c)insert in numerical order in the column headed “Circumstances”: C12351
Schedule 1, Part 1, entry for Levetiracetam in the form Oral solution 100 mg per mL, 300 mL
omit from the column headed “Responsible Person” for the brand “Kerron”: DO substitute: ZS
Schedule 1, Part 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g
omit from the column headed “Responsible Person” for the brand “Levactam”: ER substitute: ZS
Schedule 1, Part 1, entry for Lorlatinib in each of the forms: Tablet 25 mg; and Tablet 100 mg
omit from the column headed “Circumstances”: C10563
Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit from the column headed “Responsible Person” for the brand “Glucobete 500”: DO substitute: ZS
Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit from the column headed “Responsible Person” for the brand “Glucobete 850”: DO substitute: ZS
Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
omit from the column headed “Responsible Person” for the brand “Glucobete 1000”: DO substitute: ZS
Schedule 1, Part 1, entry for Metoprolol in each of the forms: Tablet containing metoprolol tartrate 50 mg; and Tablet containing metoprolol tartrate 100 mg
omit from the column headed “Responsible Person” for the brand “Mistrom”: ER substitute: ZS
Schedule 1, Part 1, entry for Nitrazepam
substitute:
| Nitrazepam | Tablet 5 mg | Oral | a | Alodorm | AF | MP NP PDP | 25 | 0 | 25 |
| a | Mogadon | IL | MP NP PDP | 25 | 0 | 25 | |||
| a | Alodorm | AF | MP NP | P6175 | 50 CN6175 | 3 CN6175 | 25 | ||
| a | Mogadon | IL | MP NP | P6175 | 50 CN6175 | 3 CN6175 | 25 | ||
| a | Alodorm | AF | MP NP | P5661 P5771 P5941 P5950 | 50 CN5661 CN5771 CN5941 CN5950 | 5 CN5661 CN5771 CN5941 CN5950 | 25 | ||
| a | Mogadon | IL | MP NP | P5661 P5771 P5941 P5950 | 50 CN5661 CN5771 CN5941 CN5950 | 5 CN5661 CN5771 CN5941 CN5950 | 25 |
Schedule 1, Part 1, entry for Olanzapine in the form Tablet 2.5 mg
omit from the column headed “Responsible Person” for the brand “Ozin 2.5”: DO substitute: ZS
Schedule 1, Part 1, entry for Olanzapine in the form Tablet 5 mg
omit from the column headed “Responsible Person” for the brand “Ozin 5”: DO substitute: ZS
Schedule 1, Part 1, entry for Olanzapine in the form Tablet 7.5 mg
omit from the column headed “Responsible Person” for the brand “Ozin 7.5”: DO substitute: ZS
Schedule 1, Part 1, entry for Olanzapine in the form Tablet 10 mg
omit from the column headed “Responsible Person” for the brand “Ozin 10”: DO substitute: ZS
Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
omit from the column headed “Responsible Person” for the brand “Panthron”: ER substitute: ZS
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]
omit from the column headed “Responsible Person” for the brand “Panthron”: ER substitute: ZS
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]
omit from the column headed “Responsible Person” for the brand “Panthron”: ER substitute: ZS
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]
omit from the column headed “Responsible Person” for the brand “Panthron”: ER substitute: ZS
Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg
omit from the column headed “Responsible Person” for the brand “PREXUM 2.5”: RW substitute: RX
Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril arginine 5 mg
omit from the column headed “Responsible Person” for the brand “PREXUM 5”: RW substitute: RX
Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg
omit from the column headed “Responsible Person” for the brand “PREXUM 10”: RW substitute: RX
Schedule 1, Part 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besilate)
omit from the column headed “Responsible Person” for the brand “Reaptan 5/5”: RW substitute: RX
Schedule 1, Part 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besilate)
omit from the column headed “Responsible Person” for the brand “Reaptan 5/10”: RW substitute: RX
Schedule 1, Part 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besilate)
omit from the column headed “Responsible Person” for the brand “Reaptan 10/5”: RW substitute: RX
Schedule 1, Part 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besilate)
omit from the column headed “Responsible Person” for the brand “Reaptan 10/10”: RW substitute: RX
Schedule 1, Part 1, entry for Perindopril with indapamide in the form Tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg
omit from the column headed “Responsible Person” for the brand “PREXUM Combi LD 2.5/0.625”: RW substitute: RX
Schedule 1, Part 1, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Perindopril/Indapamide | TX | MP NP | C4375 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Perindopril with indapamide in the form Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg
omit from the column headed “Responsible Person” for the brand “Prexum Combi 5/1.25”: RW substitute: RX
Schedule 1, Part 1, entry for Pindolol
omit:
| Tablet 5 mg (USP) | Oral | APO-PINDOL | DZ | MP NP | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and Tablet
45 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Actos”: TK substitute: EW
Schedule 1, Part 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
omit from the column headed “Responsible Person” for the brand “Kaptan”: ER substitute: ZS
Schedule 1, Part 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
omit from the column headed “Responsible Person” for the brand “Kaptan”: ER substitute: ZS
Schedule 1, Part 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
omit from the column headed “Responsible Person” for the brand “Kaptan”: ER substitute: ZS
Schedule 1, Part 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
omit from the column headed “Responsible Person” for the brand “Kaptan”: ER substitute: ZS
Schedule 1, Part 1, entry for Raloxifene
omit from the column headed “Responsible Person” for the brand “Fixta 60”: DO substitute: ZS
Schedule 1, Part 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]
omit from the column headed “Responsible Person” for the brand “Rispernia”: ER substitute: ZS
Schedule 1, Part 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]
omit from the column headed “Responsible Person” for the brand “Rispernia”: ER substitute: ZS
Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]
omit from the column headed “Responsible Person” for the brand “Rispernia”: ER substitute: ZS
Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]
omit from the column headed “Responsible Person” for the brand “Rispernia”: ER substitute: ZS
Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]
omit from the column headed “Responsible Person” for the brand “Rispernia”: ER substitute: ZS
Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]
omit from the column headed “Responsible Person” for the brand “Rispernia”: ER substitute: ZS
Schedule 1, Part 1, entry for Risperidone in the form Tablet 3 mg
omit from the column headed “Responsible Person” for the brand “Rispernia”: ER substitute: ZS
Schedule 1, Part 1, entry for Risperidone in the form Tablet 4 mg
omit from the column headed “Responsible Person” for the brand “Rispernia”: ER substitute: ZS
Schedule 1, Part 1, after entry for Tocilizumab in the form Concentrate for injection 80 mg in 4 mL
insert:
| Concentrate for injection 80 mg in 4 mL s19A | Injection | RoActemra | DZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) |
| MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 4 | PB(100) |
Schedule 1, Part 1, after entry for Tocilizumab in the form Concentrate for injection 200 mg in 10 mL
insert:
| Concentrate for injection 200 mg in 10 mL s19A | Injection | RoActemra | DZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) |
| MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 4 | PB(100) |
Schedule 1, Part 1, after entry for Tocilizumab in the form Concentrate for injection 400 mg in 20 mL
insert:
| Concentrate for injection 400 mg in 20 mL s19A | Injection | RoActemra | DZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) |
| MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 4 | PB(100) |
Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12366
Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12366
(b)insert in numerical order in the column headed “Purposes”: P12354 P12366
Schedule 1, Part 1, entry for Topiramate in the form Tablet 100 mg
insert in numerical order in the column headed “Circumstances” (all instances): C5325
Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg
omit from the column headed “Responsible Person” for the brand “Kanjinti”: AN substitute: JU
Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 420 mg
omit from the column headed “Responsible Person”: AN substitute: JU
Schedule 1, Part 1, entry for Triptorelin in the form Powder for I.M. injection (prolonged release) 22.5 mg (as embonate) with solvent, syringe and needles
insert in the column headed “Circumstances”: C12351 C12387 C12397
Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 3]
insert in numerical order in the column headed “Circumstances”: C12354 C12366
Schedule 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C12354 C12366
(b)insert in numerical order in the column headed “Purposes”: P12354 P12366
Schedule 1, Part 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Shilova 500”: DO substitute: ZS
Schedule 1, Part 2, omit entry for Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid
Schedule 1, Part 2, omit entry for Bisacodyl
Schedule 1, Part 2, omit entry for Bortezomib
Schedule 1, Part 2
insert as first entry:
| Calcipotriol with betamethasone | Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g | Application | Daivobet 50/500 gel | LO | MP NP | C7947 | 1 | 1 | 1 |
Schedule 1, Part 2, omit entry for Darunavir
Schedule 1, Part 2, omit entry for Diclofenac
Schedule 1, Part 2, omit entry for Erythromycin
Schedule 1, Part 2, omit entry for Grazoprevir with elbasvir
Schedule 1, Part 2, omit entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
Schedule 1, Part 2, omit entry for Indometacin
Schedule 1, Part 2, omit entry for Ketoconazole
Schedule 1, Part 2, omit entry for Macrogol 3350
Schedule 1, Part 2, omit entry for Metformin with glibenclamide
Schedule 1, Part 2, omit entry for Naproxen
Schedule 1, Part 2, omit entry for Nitrazepam
Schedule 1, Part 2, omit entry for Olaparib
Schedule 1, Part 2, omit entry for Phenoxybenzamine
Schedule 1, Part 2, omit entry for Sucralfate
Schedule 1, Part 2, omit entry for Tamoxifen
Schedule 1, Part 2, omit entry for Testosterone
Schedule 1, Part 2, omit entry for Verapamil
Schedule 3, details relevant to Responsible Person code DX
omit from the column headed “Responsible Person”: Ascensia Diabetes Care Australia Pty Ltd substitute: Ascensia Diabetes Care Australia Pty Limited
Schedule 3, details relevant to Responsible Person code EO
omit from the column headed “Responsible Person”: Ego Pharmaceuticals Proprietary Limited substitute: Ego Pharmaceuticals Pty Ltd
Schedule 3
omit:
| ER | Eris Pharmaceuticals (Australia) Pty Ltd | 64 139 968 139 |
Schedule 3
omit:
| XM | The Medicines Company (Australia) Pty Limited | 74 138 555 021 |
Schedule 3, after details relevant to Responsible Person code ZP
insert:
| ZS | Strides Pharma Science Pty Ltd | 44 635 036 734 |
Schedule 4, Part 1, entry for Abatacept
insert in numerical order after existing text:
| C12378 | P12378 | Severe active rheumatoid arthritis First continuing treatment - Critical shortage of tocilizumab - Temporary listing Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. | Compliance with Written Authority Required procedures |
| C12385 | P12385 | Severe active rheumatoid arthritis Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided. If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 5 repeats. Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 5 repeats. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Abemaciclib
substitute:
| Abemaciclib | C12348 | Locally advanced or metastatic breast cancer Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received treatment with this drug for this PBS indication prior to 1 November 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 cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS supply was initiated; OR Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) 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 another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. Patient must not be premenopausal. | Compliance with Authority Required procedures |
| C12367 | Locally advanced or metastatic breast cancer Initial treatment Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; OR Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) 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 a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of: (i) anastrozole, (ii) letrozole, (iii) fulvestrant; OR The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. Patient must not be premenopausal. | Compliance with Authority Required procedures | |
| C12380 | Locally advanced or metastatic breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must be in combination with one of: (i) anastrozole, (ii) letrozole, (iii) fulvestrant; AND The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. Patient must not be premenopausal. | Compliance with Authority Required procedures |
Schedule 4, Part 1, omit entry for Grazoprevir with elbasvir
Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
omit:
| C6858 | Ketogenic diet Patient must have intractable seizures requiring treatment with a ketogenic diet; OR Patient must have a glucose transport protein defect; OR Patient must have pyruvate dehydrogenase deficiency. Keyo should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist. |
Schedule 4, Part 1, entry for IncobotulinumtoxinA
omit:
| C10594 | Moderate to severe spasticity of the upper limb following an acute event Grandfather treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2020; AND The condition must have been moderate to severe spasticity of the upper limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more prior to commencing non-PBS subsidised treatment; AND The treatment must only be used as second line therapy when standard management has failed; OR The treatment must only be used as an adjunct to physical therapy; AND The treatment must not continue if the patient did not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND Patient must not have established severe contracture in the limb to be treated. Patient must be aged 18 years or older. Must be treated by a neurologist; OR Must be treated by an orthopaedic surgeon; OR Must be treated by a rehabilitation specialist; OR Must be treated by a plastic surgeon; OR Must be treated by a geriatrician. Standard management includes physiotherapy and/or oral spasticity agents. | Compliance with Authority Required procedures - Streamlined Authority Code 10594 |
Schedule 4, Part 1, entry for Infliximab
insert in numerical order after existing text:
| C12363 | P12363 | Severe active rheumatoid arthritis Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) - Balance of Supply Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received insufficient therapy with this drug for this condition under the Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) restriction, with subcutaneous form restriction to complete 22 weeks initial treatment (intravenous and subcutaneous inclusive); AND The treatment must provide no more than the balance of up to 22 weeks treatment available under the - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) - subcutaneous form. Patient must be aged 18 years or older. | Compliance with Authority Required procedures |
| C12378 | P12378 | Severe active rheumatoid arthritis First continuing treatment - Critical shortage of tocilizumab - Temporary listing Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. | Compliance with Written Authority Required procedures |
| C12390 | P12390 | Severe active rheumatoid arthritis Initial treatment - Initial 4 (Temporary listing - Change of treatment due to critical shortage of tocilizumab) - subcutaneous form at weeks 6, 8, 10, 12, 14 and 16 Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND Patient must have received 2 intravenous infusions with this drug for this condition at weeks 0 and 2 under Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided. If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Leuprorelin
(a)omit:
| C6422 | Central precocious puberty Continuing treatment Must be treated by a medical practitioner in consultation with a paediatric endocrinologist; OR Must be treated by a medical practitioner in consultation with an endocrinologist specialising in paediatrics. Patient must have previously been issued with an authority prescription for this drug for this condition. |
(b)omit:
| C6426 | Central precocious puberty Initial - grandfather Patient must have received treatment with a gonadotropin releasing hormone analogue (GnRHa) for this condition prior to 1 May 2015. Must be treated by a paediatric endocrinologist; OR Must be treated by an endocrinologist specialising in paediatrics. |
(c)insert in numerical order after existing text:
| C12351 | Central precocious puberty Continuing treatment with this drug, or, switching gonadotropin releasing hormone analogue therapy Must be treated by a medical practitioner identifying as one of: (i) a paediatric endocrinologist, (ii) an endocrinologist specialising in paediatrics; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND Patient must be undergoing continuing treatment with a gonadotropin releasing hormone analogue initiated through the PBS for this PBS indication. |
Schedule 4, Part 1, entry for Lorlatinib
omit:
| C10563 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfather treatment Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2020; AND The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment; AND The condition must have progressed following treatment with an ALK inhibitor other than crizotinib prior to commencement of non-PBS-subsidised treatment with this drug for this PBS indication; AND Patient must not have progressive disease while receiving treatment with this drug for this condition. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Tamoxifen
omit:
| C6470 | Breast cancer The condition must be hormone receptor positive. | C6470 |
Schedule 4, Part 1, entry for Tofacitinib
insert in numerical order after existing text:
| C12354 | P12354 | Severe active rheumatoid arthritis Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times. Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided. If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C12366 | P12366 | Severe active rheumatoid arthritis First continuing treatment - Critical shortage of tocilizumab - Temporary listing Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Triptorelin
insert in numerical order after existing text:
| C12351 | Central precocious puberty Continuing treatment with this drug, or, switching gonadotropin releasing hormone analogue therapy Must be treated by a medical practitioner identifying as one of: (i) a paediatric endocrinologist, (ii) an endocrinologist specialising in paediatrics; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND Patient must be undergoing continuing treatment with a gonadotropin releasing hormone analogue initiated through the PBS for this PBS indication. |
| C12387 | Central precocious puberty Initial treatment Must be treated by a paediatric endocrinologist; OR Must be treated by an endocrinologist specialising in paediatrics. Patient must be of an age that is prior to their 12thbirthday if female; OR Patient must be of an age that is prior to their 13thbirthday if male; AND Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9thbirthday if female; OR Patient must have had onset of signs/symptoms of central precocious puberty prior to their 10thbirthday if male. |
| C12397 | Central precocious puberty Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements Must be treated by a paediatric endocrinologist; OR Must be treated by an endocrinologist specialising in paediatrics; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion. Patient must be each of: (i) currently receiving this drug for the PBS-indication, (ii) commenced on non-PBS-subsidised supply prior to 1 November 2021. Patient must have met each of: (i) experienced signs/symptoms of central precocious puberty prior to their 9thbirthday, (ii) initiated treatment with this drug prior to their 12thbirthday, if female; OR Patient must have met each of: (i) experienced signs/symptoms of central precocious puberty prior to their 10thbirthday, (ii) initiated treatment with this drug prior to their 13thbirthday, if male. |
Schedule 4, Part 1, entry for Upadacitinib
insert in numerical order after existing text:
| C12354 | P12354 | Severe active rheumatoid arthritis Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times. Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided. If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C12366 | P12366 | Severe active rheumatoid arthritis First continuing treatment - Critical shortage of tocilizumab - Temporary listing Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. | Compliance with Written Authority Required procedures |
Schedule 5, entry for Imatinib in the form Tablet 100 mg (as mesilate) [GRP-21076]
insert in alphabetical order in the column headed “Brand” Imatinib-Teva
Schedule 5, after entry for Imatinib in the form Tablet 100 mg (as mesilate) [GRP-21076]
insert:
| GRP-25645 | Capsule 100 mg (as mesilate) | Oral | IMATINIB-DRLA Imatinib-APOTEX |
| Tablet 100 mg (as mesilate) | Oral | Gilmat Glivec Imatinib-Teva | |
| GRP-25646 | Capsule 100 mg (as mesilate) | Oral | IMATINIB-DRLA |
| Tablet 100 mg (as mesilate) | Oral | Gilmat Glivec Imatinib-Teva |
Schedule 5, entry for Imatinib in the form Tablet 400 mg (as mesilate) [GRP-21080]
insert in alphabetical order in the column headed “Brand”: Imatinib-Teva
Schedule 5, after entry for Imatinib in the form Tablet 400 mg (as mesilate) [GRP-21080]
insert:
| GRP-25647 | Capsule 400 mg (as mesilate) | Oral | IMATINIB-DRLA |
| Tablet 400 mg (as mesilate) | Oral | Gilmat Glivec Imatinib-Teva | |
| GRP-25684 | Capsule 400 mg (as mesilate) | Oral | IMATINIB-DRLA Imatinib-APOTEX |
| Tablet 400 mg (as mesilate) | Oral | Gilmat Glivec Imatinib-Teva |
Schedule 5, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
insert in alphabetical order in the column headed “Brand”: APO-Perindopril/Indapamide
Schedule 5, omit entry for Pindolol
Schedule 5, after entry for Tiotropium in the form Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler) [GRP-23704]
insert:
| Tocilizumab | GRP-25653 | Concentrate for injection 400 mg in 20 mL | Injection | Actemra |
| Concentrate for injection 400 mg in 20 mL s19A | Injection | RoActemra | ||
| GRP-25663 | Concentrate for injection 80 mg in 4 mL | Injection | Actemra | |
| Concentrate for injection 80 mg in 4 mL s19A | Injection | RoActemra | ||
| GRP-25697 | Concentrate for injection 200 mg in 10 mL | Injection | Actemra | |
| Concentrate for injection 200 mg in 10 mL s19A | Injection | RoActemra |
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