Federal Register of Legislation - Australian Government

Primary content

PB 87 of 2021 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 31 Aug 2021
Tabling HistoryDate
Tabled HR01-Sep-2021
Tabled Senate02-Sep-2021
To be repealed 11 Feb 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

 

PB 87 of 2021

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 8)

 

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                  27 August 2021

 

 

 

 

 

 

 

 

 

 

 

 

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

________________________________________________________________________

 


 

1          Name of Instrument

(1)          This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 8).

(2)          This instrument may also be cited as PB 87 of 2021.

2          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 September 2021

1 September 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Note:    This table relates only to the provisions of this instrument as originally made.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.

3          Authority

This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

4          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)

[1]             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”: C6944                substitute: C12173

[2]             Schedule 1, Part 1, entry for Adalimumab

                           substitute:

Adalimumab

Injection 20 mg in 0.2 mL pre-filled syringe

Injection

 

Humira

VE

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

 

 

MP

C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P11713

2

0

2

 

 

 

 

 

 

 

 

MP

C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P9715 P11715 P11716 P11761 P11852 P11854 P11855

2

3

2

 

 

 

 

 

 

 

 

MP

C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P11717 P11767 P11853 P11903 P11966

2

5

2

 

 

 

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

 

Amgevita

AN

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

C(100)

 

 

 

 

 

 

MP

C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P11713

2

0

1

 

 

 

 

 

 

 

 

MP

C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P9715 P11715 P11716 P11761 P11852 P11854 P11855

2

3

1

 

 

 

 

 

 

 

 

MP

C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P11579 P11717 P11718 P11767 P11853 P11903 P11966

2

5

1

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

1

 

C(100)

 

Injection 40 mg in 0.4 mL pre-filled pen

Injection

 

Humira

VE

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6946

4

2

2

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6946

4

2

4

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11534 P11624

4

5

2

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11534 P11624

4

5

4

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6963 P9715 P10892 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

 

 

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11534 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6963 P9715 P10892 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

6

 

 

 

Injection 40 mg in 0.4 mL pre-filled syringe

Injection

 

Humira

VE

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

6

 

 

 

Injection 40 mg in 0.8 mL pre-filled pen

Injection

 

Amgevita

AN

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Hadlima

RF

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Hyrimoz

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Idacio

PK

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Amgevita

AN

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

Hadlima

RF

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

Idacio

PK

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

Amgevita

AN

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Hadlima

RF

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Idacio

PK

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Amgevita

AN

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Hadlima

RF

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Idacio

PK

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Amgevita

AN

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Hadlima

RF

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Idacio

PK

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Amgevita

AN

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Hadlima

RF

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Hyrimoz

SZ

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Idacio

PK

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Amgevita

AN

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6946

4

2

2

 

 

 

 

 

 

Hadlima

RF

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6946

4

2

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6946

4

2

2

 

 

 

 

 

 

Idacio

PK

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6946

4

2

2

 

 

 

 

 

 

Amgevita

AN

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11529 P11534 P11624

4

5

2

 

 

 

 

 

 

Hadlima

RF

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11529 P11534 P11624

4

5

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11529 P11534 P11624

4

5

2

 

 

 

 

 

 

Idacio

PK

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11529 P11534 P11624

4

5

2

 

 

 

 

 

 

Amgevita

AN

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6963 P9715 P10892 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

Hadlima

RF

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6963 P9715 P10892 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6963 P9715 P10892 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

Idacio

PK

MP

C6946 C6963 C8638 C9064 C9386 C9715 C10892 C11107 C11523 C11524 C11529 C11534 C11579 C11604 C11605 C11606 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P6963 P9715 P10892 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

 

Amgevita

AN

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Hadlima

RF

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Hyrimoz

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Idacio

PK

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11713

2

0

2

 

 

 

 

 

 

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

Injection 80 mg in 0.8 mL pre-filled pen

Injection

 

Humira

VE

MP

C6946 C6963 C10838 C10892 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229

P12103 P12105 P12153 P12155 P12161 P12212

1

0

1

 

 

 

 

 

 

 

 

MP

C6946 C6963 C10838 C10892 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229

P6946

2

2

1

 

 

 

 

 

 

 

 

MP

C6946 C6963 C10838 C10892 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229

P10838

2

5

1

 

 

 

 

 

 

 

 

MP

C6946 C6963 C10838 C10892 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229

P6963 P10892 P11758 P11759 P11761 P11762 P11763 P11789 P11852 P11854 P11855 P12152 P12229

3

0

1

 

 

 

Injection 80 mg in 0.8 mL pre-filled syringe

Injection

 

Humira

VE

MP

C6946 C6963 C10838 C10892 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229

P12103 P12105 P12153 P12155 P12161 P12212

1

0

1

 

 

 

 

 

 

 

 

MP

C6946 C6963 C10838 C10892 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229

P6946

2

2

1

 

 

 

 

 

 

 

 

MP

C6946 C6963 C10838 C10892 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229

P10838

2

5

1

 

 

 

 

 

 

 

 

MP

C6946 C6963 C10838 C10892 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229

P6963 P10892 P11758 P11759 P11761 P11762 P11763 P11789 P11852 P11854 P11855 P12152 P12229

3

0

1

 

 

[3]             Schedule 1, Part 1, entry for Adrenaline (epinephrine) in the form I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector

                   (a)        omit from the column headed “Maximum Quantity” (all instances): 1               substitute: 2

                   (b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Anapen Junior 150

XT

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

[4]             Schedule 1, Part 1, entry for Adrenaline (epinephrine) in the form I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector

                   (a)        omit from the column headed “Maximum Quantity” (all instances): 1               substitute: 2

                   (b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Anapen 300

XT

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

[5]             Schedule 1, Part 1, after entry for Adrenaline (epinephrine) in the form I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector

insert:

 

I.M. injection 500 micrograms in 0.3 mL single dose syringe auto-injector

Injection

 

Anapen 500

XT

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

[6]             Schedule 1, Part 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides in the form Oral powder 400 g (Neocate Junior)

                           insert:

 

Oral powder 800 g (Essential Care Jr)

Oral

 

Essential Care Jr

QH

MP NP

C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 C4415 C5945 C5974

 

4

5

1

 

 

[7]             Schedule 1, Part 1, entry for Brentuximab vedotin

                   (a)        omit from the column headed “Circumstances”: C4675 C7616

                   (b)        insert in numerical order in the column headed “Circumstances”: C12085 C12087 C12088 C12141

[8]             Schedule 1, Part 1, after entry for Carfilzomib in the form Powder for injection 60 mg

                           insert:

Cariprazine

Capsule 1.5 mg

Oral

 

Reagila

CS

MP NP

C4246

 

30

5

30

 

 

 

Capsule 3 mg

Oral

 

Reagila

CS

MP NP

C4246

 

30

5

30

 

 

 

Capsule 4.5 mg

Oral

 

Reagila

CS

MP NP

C4246

 

30

5

30

 

 

 

Capsule 6 mg

Oral

 

Reagila

CS

MP NP

C4246

 

30

5

30

 

 

[9]             Schedule 1, Part 1, after entry for Deferasirox in the form Tablet 90 mg

                           insert:

 

Tablet, dispersible, 125 mg

Oral

 

Deferasirox Juno

JU

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

168

2

28

 

D(100)

 

 

 

 

 

 

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

168

5

28

 

D(100)


 

[10]           Schedule 1, Part 1, after entry for Deferasirox in the form Tablet 180 mg

                           insert:

 

Tablet, dispersible, 250 mg

Oral

 

Deferasirox Juno

JU

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

168

2

28

 

D(100)

 

 

 

 

 

 

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

168

5

28

 

D(100)

[11]           Schedule 1, Part 1, after entry for Deferasirox in the form Tablet 360 mg

                           insert:

 

Tablet, dispersible, 500 mg

Oral

 

Deferasirox Juno

JU

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

168

2

28

 

D(100)

 

 

 

 

 

 

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

168

5

28

 

D(100)

[12]           Schedule 1, Part 1, entry for Diazepam in the form Oral liquid 1 mg in 1 mL, 100 mL

                           omit from the column headed “Form”: Oral liquid 1 mg in 1 mL, 100 mL           substitute: Oral liquid 10 mg per 10 mL, 100 mL

[13]           Schedule 1, Part 1, entry for Diazepam in the form Tablet 2 mg [Maximum Quantity: 50; Number of Repeats: 0]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APX-Diazepam

TY

MP NP PDP

 

 

50

0

50

 

 

[14]           Schedule 1, Part 1, entry for Diazepam in the form Tablet 2 mg [Maximum Quantity: 50; Number of Repeats: 3]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APX-Diazepam

TY

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

[15]           Schedule 1, Part 1, entry for Diazepam in the form Tablet 5 mg [Maximum Quantity: 50; Number of Repeats: 0]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APX-Diazepam

TY

MP NP PDP

 

 

50

0

50

 

 

[16]           Schedule 1, Part 1, entry for Diazepam in the form Tablet 5 mg [Maximum Quantity: 50; Number of Repeats: 3]

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APX-Diazepam

TY

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

[17]           Schedule 1, Part 1, entry for Enzalutamide

                           omit from the column headed “Circumstances”: C4670                substitute: C12216

[18]           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]

                   (a)        omit from the column headed “Circumstances”: C9375

                   (b)        insert in numerical order in the column headed “Circumstances”: C12164

                   (c)        omit from the column headed “Purposes”: P9375

                   (d)        insert in numerical order in the column headed “Purposes”: P12164

[19]           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)        omit from the column headed “Circumstances”: C9375

                   (b)        insert in numerical order in the column headed “Circumstances”: C12164

[20]           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]

                   (a)        omit from the column headed “Circumstances”: C9375

                   (b)        insert in numerical order in the column headed “Circumstances”: C12164

                   (c)        omit from the column headed “Purposes”: P9375

                   (d)        insert in numerical order in the column headed “Purposes”: P12164

[21]           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)        omit from the column headed “Circumstances”: C9375

                   (b)        insert in numerical order in the column headed “Circumstances”: C12164

[22]           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]

                   (a)        omit from the column headed “Circumstances”: C9375

                   (b)        insert in numerical order in the column headed “Circumstances”: C12164

                   (c)        omit from the column headed “Purposes”: P9375

                   (d)        insert in numerical order in the column headed “Purposes”: P12164

[23]           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)        omit from the column headed “Circumstances”: C9375

                   (b)        insert in numerical order in the column headed “Circumstances”: C12164

[24]           Schedule 1, Part 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

                           insert in the column headed “Schedule Equivalent” (all instances): a

[25]           Schedule 1, Part 1, entry for Fluoxetine

                           omit:

 

Capsule 20 mg (as hydrochloride) (USP)

Oral

 

Fluoxetine Capsule (USP)

DZ

MP NP

C4755 C6277

 

28

5

100

 

 

[26]           Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Pressurised inhalation containing fluticasone propionate
125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Evocair MDI

AF

MP NP

C4930

 

1

5

1

 

 

[27]           Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Pressurised inhalation containing fluticasone propionate
250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Evocair MDI

AF

MP NP

C4930 C10121

 

1

5

1

 

 

[28]           Schedule 1, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

                           omit:

 

Oral semi-solid 100 g, 48 (Keyo)

Oral

 

Keyo

VF

MP NP

C6858

 

3

5

1

 

 

[29]           Schedule 1, Part 1, after entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate in the form Oral liquid 250 mL, 30 (KetoVie 4:1)

                           insert:

 

Oral semi-solid 100 g, 36 (K.Yo)

Oral

 

K.Yo

VF

MP NP

C12096

 

4

5

1

 

 

[30]           Schedule 1, Part 1, entry for Lacosamide in the form Oral solution 10 mg per mL, 200 mL

                           substitute:

 

Oral solution 10 mg per mL,
200 mL

Oral

 

Vimpat

UC

MP NP

C8770 C8815 C12092

P12092

2

5

1

 

 

 

 

 

 

 

 

MP NP

C8770 C8815 C12092

P8770 P8815

6

5

1

 

 

[31]           Schedule 1, Part 1, entry for Lacosamide in the form Tablet 50 mg [Maximum Quantity: 14; Number of Repeats: 1]

                           insert in numerical order in the column headed “Circumstances”: C12092

[32]           Schedule 1, Part 1, entry for Lacosamide in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 5]

                   (a)        insert in numerical order in the column headed “Circumstances”: C12092

                   (b)        insert in numerical order in the column headed “Purposes”: P12092

[33]           Schedule 1, Part 1, entry for Lacosamide in the form Tablet 100 mg

                           substitute:

 

Tablet 100 mg

Oral

 

Vimpat

UC

MP

C8770 C8813 C8815 C12092 C12225

P8813 P12225

14

1

14

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092

P8813

14

1

14

 

 

 

 

 

 

 

 

MP

C8770 C8813 C8815 C12092 C12225

P8770 P8815 P12092

56

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092

P8770 P8815 P12092

56

5

56

 

 

[34]           Schedule 1, Part 1, entry for Lacosamide in the form Tablet 150 mg

                           substitute:

 

Tablet 150 mg

Oral

 

Vimpat

UC

MP

C8770 C8813 C8815 C12092 C12225

P8813 P12225

14

1

14

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092

P8813

14

1

14

 

 

 

 

 

 

 

 

MP

C8770 C8813 C8815 C12092 C12225

P8770 P8815 P12092

56

5

56

 

 

 

 

 

 

 

 

NP

C8770 C8813 C8815 C12092

P8770 P8815 P12092

56

5

56

 

 

[35]           Schedule 1, Part 1, entry for Lacosamide in the form Tablet 200 mg

                           insert in numerical order in the column headed “Circumstances”: C12092

[36]           Schedule 1, Part 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

                           insert in the column headed “Schedule Equivalent” (all instances): a

[37]           Schedule 1, Part 1, entry for Metformin

                           omit:

 

Tablet (prolonged release) containing metformin hydrochloride 500 mg

Oral

 

Metformin (Medsurge)

DZ

MP NP

 

 

120

5

56

 

 

[38]           Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 15 mg

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APX-Mirtazapine

TY

MP NP

C5650

 

30

5

30

 

 

[39]           Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 30 mg

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APX-Mirtazapine

TY

MP NP

C5650

 

30

5

30

 

 

[40]           Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

APX-Mirtazapine

TY

MP NP

C5650

 

30

5

30

 

 

[41]           Schedule 1, Part 1, after entry for Nystatin in the form Tablet 500,000 units

                           insert:

Obeticholic acid

Tablet 5 mg

Oral

 

Ocaliva

EU

MP

C12084 C12138 C12140

 

30

5

30

 

 

 

 

 

 

 

 

NP

C12138 C12140

 

30

5

30

 

 

 

Tablet 10 mg

Oral

 

Ocaliva

EU

MP NP

C12138 C12140

 

30

5

30

 

 

[42]           Schedule 1, Part 1, entry for Olaparib

                           omit:

 

Capsule 50 mg

Oral

 

Lynparza

AP

MP

C10937

 

448

5

448

 

 

 


 

[43]           Schedule 1, Part 1, after entry for Prednisolone in the form Oral solution 5 mg (as sodium phosphate) per mL, 30 mL

                           insert:

Prednisolone acetate

Eye drops containing prednisolone acetate 10 mg per mL, 10 mL

Application to the eye

 

PRED FORTE

AG

AO

C6087

 

1

0

1

 

 

 

 

 

 

 

 

MP

C6080 C6101 C10095

P10095

1

0

1

 

 

 

 

 

 

 

 

MP

C6080 C6101 C10095

P6080 P6101

1

2

1

 

 

 

 

 

 

 

 

NP

C6080 C6101

 

1

2

1

 

 

[44]           Schedule 1, Part 1, entry for Semaglutide in each of the forms: Solution for injection 2 mg in 1.5 mL pre-filled pen; and Solution for injection
4 mg in 3 mL pre-filled pen

                           insert in numerical order in the column headed “Circumstances”: C5469

[45]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[46]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 1]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[47]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[48]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

                   (c)        omit from the column headed “Purposes”: P9390

                   (d)        insert in numerical order in the column headed “Purposes”: P12193


 

[49]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[50]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 6]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[51]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[52]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 1]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[53]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[54]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

                   (c)        omit from the column headed “Purposes”: P9390

                   (d)        insert in numerical order in the column headed “Purposes”: P12193

[55]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[56]           Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 6]

                   (a)        omit from the column headed “Circumstances”: C9390

                   (b)        insert in numerical order in the column headed “Circumstances”: C12193

[57]           Schedule 1, Part 1, entry for Trihexyphenidyl

                           omit:

 

Tablet containing trihexyphenidyl hydrochloride
2 mg (USP)

Oral

 

Trihexyphenidyl hydrochloride USP (Medsurge)

DZ

MP NP

 

 

200

2

100

 

 

[58]           Schedule 1, Part 1, entry for Vedolizumab

                           insert as first entry:

Vedolizumab

Injection 108 mg in 0.68 mL single use pre-filled pen

Injection

 

Entyvio

TK

MP

C12077 C12078 C12178 C12218 C12242 C12243 C12244 C12250

P12218 P12242 P12243 P12250

2

0

2

 

 

 

 

 

 

 

 

MP

C12077 C12078 C12178 C12218 C12242 C12243 C12244 C12250

P12077 P12078 P12178 P12244

2

5

2

 

 

[59]           Schedule 1, Part 1, entry for Vedolizumab in the form Powder for injection 300 mg

                           omit from the column headed “Section 100/ Prescriber Bag only”: D(100)                    substitute: PB(100)

[60]           Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

                           omit:

 

 

 

 

DBL Zoledronic Acid

PF

MP

C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328

 

1

11

1

 

PB(100)

[61]           Schedule 1, Part 2, after entry for Grazoprevir with elbasvir

insert:

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Oral semi-solid 100 g, 48 (Keyo)

Oral

 

Keyo

VF

MP NP

C6858

 

3

5

1

 

 

[62]           Schedule 1, Part 2, omit entry for Interferon alfa-2a

[63]           Schedule 1, Part 2, after entry for Nitrazepam

insert:

Olaparib

Capsule 50 mg

Oral

 

Lynparza

AP

MP

C10937

 

448

5

448

 

 

[64]           Schedule 1, Part 2, entry for Zoledronic acid

insert as first entry:

 

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Injection

 

DBL Zoledronic Acid

PF

MP

C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328

 

1

11

1

 

PB(100)

[65]           Schedule 3, details relevant to Responsible Person code NE

omit from the column headed “Responsible Person: Norgine Pty Limited            substitute: Norgine Pty. Ltd.

[66]           Schedule 3, details relevant to each of the Responsible Person codes: NF; and NI

omit from the column headed “Responsible Person”: Novo Nordisk Pharmaceuticals Pty Limited     substitute: Novo Nordisk Pharmaceuticals Pty. Limited

[67]           Schedule 3, details relevant to Responsible Person code NO

omit from the column headed “Responsible Person”: Novo Nordisk Pharmaceuticals Pty Limited     substitute: Novo Nordisk Pharmaceuticals Pty. Limited

[68]           Schedule 4, Part 1, entry for Abiraterone

                           substitute:

Abiraterone

C12173

 

 

Castration resistant metastatic carcinoma of the prostate
The treatment must be used in combination with a corticosteroid; AND
The treatment must not be used in combination with chemotherapy; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone; AND
Patient must not have received prior treatment with enzalutamide; OR
Patient must have developed intolerance to enzalutamide of a severity necessitating permanent treatment withdrawal.

Compliance with Authority Required procedures

[69]           Schedule 4, Part 1, entry for Adalimumab

                   (a)        omit from the column headed “Purposes Code” for circumstances code “C11526”: P11526

                   (b)        omit:

 

C11559

P11559

 

Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 1 month old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this 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.

Compliance with Written Authority Required procedures

                   (c)        omit:

 

C11613

P11613

 

Complex refractory Fistulising Crohn disease
Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy following a minimum of 12 weeks of therapy.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this 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.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.

Compliance with Written Authority Required procedures

                   (d)        insert in numerical order after existing text:

 

C12098

P12098

 

Complex refractory Fistulising Crohn disease
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
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.
Applications for authorisation must be made in writing and must include:
(1) two completed authority prescription forms; 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) which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 4 weeks old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.

Compliance with Written Authority Required procedures

 

C12101

P12101

 

Complex refractory Fistulising Crohn disease
Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

Compliance with Authority Required procedures

 

C12103

P12103

 

Severe chronic plaque psoriasis
Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
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 within this treatment cycle.

Compliance with Written Authority Required procedures

 

C12105

P12105

 

Severe chronic plaque psoriasis
Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

 

C12116

 

 

Severe active juvenile idiopathic arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; 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.
An adequate response to treatment is defined as:
(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, cervical spine 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).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 12116

 

C12118

P12118

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
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 a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
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 to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine 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).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measurements must be no more than 4 weeks old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
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 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C12122

P12122

 

Severe active juvenile idiopathic arthritis
First continuing treatment
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; 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) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) 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, cervical spine 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 fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C12123

P12123

 

Severe active juvenile idiopathic arthritis
Continuing treatment - 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 first continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.

Compliance with Authority Required procedures

 

C12130

P12130

 

Ankylosing spondylitis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(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) which includes the following:
(i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a BASDAI score.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C12131

P12131

 

Ankylosing spondylitis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(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 a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 4 weeks old at the time of application.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12147

P12147

 

Complex refractory Fistulising Crohn disease
Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(1) two completed authority prescription forms; 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) which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 4 weeks old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
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.

Compliance with Written Authority Required procedures

 

C12148

P12148

 

Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug for this condition.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation 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) which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 4 weeks old at the time of application.
An application for the continuing treatment must be accompanied with the assessment of response 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.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.
A maximum of 24 weeks treatment will be authorised under this restriction.

Compliance with Written Authority Required procedures

 

C12152

P12152

 

Complex refractory Fistulising Crohn disease
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
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.
Applications for authorisation must be made in writing and must include:
(1) two completed authority prescription forms; 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) which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 4 weeks old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.

Compliance with Written Authority Required procedures

 

C12153

P12153

 

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
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 within this treatment cycle.

Compliance with Written Authority Required procedures

 

C12155

P12155

 

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12156

P12156

 

Severe chronic plaque psoriasis
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply
Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Must be treated by a dermatologist.

Compliance with Authority Required procedures

 

C12157

P12157

 

Severe chronic plaque psoriasis
Subsequent continuing treatment, Whole body
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
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 fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12158

P12158

 

Severe chronic plaque psoriasis
First continuing treatment, Whole body
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); 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.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
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 fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12161

P12161

 

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
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.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

 

C12171

P12171

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; OR
Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine 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).
All measurements must be no more than 4 weeks old at the time of this application.
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).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C12174

P12174

 

Ankylosing spondylitis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

 

C12175

P12175

 

Ankylosing spondylitis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

 

C12176

P12176

 

Ankylosing spondylitis
Subsequent continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(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 adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 4 weeks old at the time of application.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12189

P12189

 

Severe chronic plaque psoriasis
First continuing treatment, Face, hand, foot
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); 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.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet and the face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.
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 fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12190

P12190

 

Severe chronic plaque psoriasis
Subsequent continuing treatment, Face, hand, foot
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet and the face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.
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 fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12194

P12194

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after break in biological medicine of less than 24 months)
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 a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
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) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) 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, cervical spine 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).
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 a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C12199

P12199

 

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(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) which includes the following:
(i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) baseline ESR and/or CRP level.
An assessment of a patient's response to 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 these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C12212

P12212

 

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); 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) which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12214

P12214

 

Severe active juvenile idiopathic arthritis
Subsequent continuing treatment
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 previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; 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) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) 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, cervical spine 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 fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient doses for up to 24 weeks treatment. Up to a maximum of 5 repeats will be authorised.
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

Compliance with Written Authority Required procedures

 

C12228

P12228

 

Complex refractory Fistulising Crohn disease
First continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug for this condition.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation 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) which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 4 weeks old at the time of application.
An application for the continuing treatment must be accompanied with the assessment of response 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.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.
A maximum of 24 weeks treatment will be authorised under this restriction.

Compliance with Written Authority Required procedures

 

C12229

P12229

 

Complex refractory Fistulising Crohn disease
Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(1) two completed authority prescription forms; 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) which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 4 weeks old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
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.

Compliance with Written Authority Required procedures

 

C12234

P12234

 

Ankylosing spondylitis
First continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(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 adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 4 weeks old at the time of application.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12240

P12240

 

Complex refractory Fistulising Crohn disease
Continuing treatment - balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.

Compliance with Authority Required procedures

[70]           Schedule 4, Part 1, entry for Brentuximab vedotin

                   (a)        omit:

 

C4675

 

 

CD30 positive systemic anaplastic large cell lymphoma
Continuing treatment
Patient must not have progressive disease; AND
Patient must have previously been issued with an authority prescription for this drug.
The treatment must not exceed a lifetime total of 16 cycles.

Compliance with Authority Required procedures

 

C7616

 

 

CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy; and
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction.

Compliance with Written Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C12085

 

 

CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease; AND
Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy; and
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction.

Compliance with Written Authority Required procedures

 

C12087

 

 

CD30 positive peripheral T-cell lymphoma, non-cutaneous type
Initial treatment
Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND
The treatment must be for first line therapy for this condition; AND
The treatment must be for curative intent; AND
The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Peripheral T-cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity;
(ii) The date of initial diagnosis of Peripheral T-cell lymphoma cell lymphoma.

Compliance with Written Authority Required procedures

 

C12088

 

 

CD30 positive peripheral T-cell lymphoma, non-cutaneous type
Continuing treatment
The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND
Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as:
(a) Positron emission tomography-based response: lymph nodes and extralymphatic sites - a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR
(b) Computed tomography-based response: lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable.

Compliance with Authority Required procedures

 

C12141

 

 

CD30 positive systemic anaplastic large cell lymphoma
Continuing treatment
Patient must not have progressive disease; AND
Patient must have previously been issued with an authority prescription for this drug.
The treatment must not be more than 12 treatment cycles under this restriction in a lifetime.

Compliance with Authority Required procedures

[71]           Schedule 4, Part 1, after entry for Carfilzomib

                           insert:

Cariprazine

C4246

 

 

Schizophrenia

Compliance with Authority Required procedures - Streamlined Authority Code 4246

[72]           Schedule 4, Part 1, entry for Enzalutamide

                           substitute:

Enzalutamide

C12216

 

 

Castration resistant metastatic carcinoma of the prostate
The treatment must not be used in combination with chemotherapy; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
Patient must not have received prior treatment with abiraterone; OR
Patient must have developed intolerance to abiraterone of a severity necessitating permanent treatment withdrawal.

Compliance with Authority Required procedures

[73]           Schedule 4, Part 1, entry for Etanercept

                   (a)        omit:

 

C9375

P9375

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
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 a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
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 to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine 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).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C12164

P12164

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
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 a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
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 to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine 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).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[74]           Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

                           insert in numerical order after existing text:

 

C12096

 

 

Ketogenic diet
Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of: (i) a metabolic physician, (ii) a neurologist.
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.

 

[75]           Schedule 4, Part 1, omit entry for Interferon alfa-2a

[76]           Schedule 4, Part 1, entry for Lacosamide

                           insert in numerical order after existing text:

 

C12092

P12092

 

Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures
Must be treated by a neurologist; OR
Must be treated by a paediatrician; AND
Must be treated by an eligible practitioner type 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.
The condition must have failed to be controlled satisfactorily by at least two anti-epileptic drugs prior to when the drug is/was first commenced; AND
The treatment must be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised anti-epileptic drug at the time the drug is/was first commenced.

Compliance with Authority Required procedures - Streamlined Authority Code 12092

 

C12225

P12225

 

Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures
Dose titration at the start of therapy, during therapy or to gradually cease treatment
Must be treated by a neurologist; OR
Must be treated by a paediatrician.
The condition must have failed to be controlled satisfactorily by at least two anti-epileptic drugs prior to when the drug is/was first commenced; AND
The treatment must be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised anti-epileptic drug at the time the drug is/was first commenced; AND
The treatment must be for dose titration purposes.

Compliance with Authority Required procedures - Streamlined Authority Code 12225

[77]           Schedule 4, Part 1, after entry for Nortriptyline

                           insert:

Obeticholic acid

C12084

 

 

Primary biliary cholangitis (previously known as Primary biliary cirrhosis)
Initial treatment
Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; 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 concurrent treatment with ursodeoxycholic acid, following this authority application; OR
Patient must be undergoing treatment with this drug as monotherapy following this authority application, because combination treatment with ursodeoxycholic acid is not tolerated.
Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; OR
Patient must have experienced an intolerance to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND
Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised; AND
Patient must have an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of 'normal', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; OR
Patient must have a total bilirubin level between 1 to 2 times the ULN, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; OR
Patient must have abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid.
Patient must be aged 18 years or older.
Document and retain in the patient's medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the 'Continuing treatment' restriction.

Compliance with Authority Required procedures

 

C12138

 

 

Primary biliary cholangitis (previously known as Primary biliary cirrhosis)
Continuing treatment
Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; OR
Must be treated by an eligible practitioner type 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 PBS-subsidised treatment with this drug, with treatment having commenced through one of: (i) the 'Initial treatment' listing, (ii) 'Grandfather' arrangements; AND
Patient must be undergoing concurrent treatment with ursodeoxycholic acid, following this authority application; OR
Patient must be undergoing treatment with this drug as monotherapy following this authority application, because combination treatment with ursodeoxycholic acid is not tolerated.
Patient must have achieved an adequate response to this drug, defined as having at least one of: (i) an alkaline phosphate (ALP) level less than 1.67 times the upper limit of normal (ULN), (ii) a reduction in the ALP reading of at least 15% compared to the baseline level provided with the initial authority application, (iii) a total bilirubin level within the normal reference range.
The improvement in the qualifying laboratory reading(s) has/have been documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 12138

 

C12140

 

 

Primary biliary cholangitis (previously known as Primary biliary cirrhosis)
Transitioning from non-PBS to PBS subsidised supply - Grandfather arrangements
Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; OR
Must be treated by an eligible practitioner type 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 concurrent treatment with ursodeoxycholic acid, following this authority application; OR
Patient must be undergoing treatment with this drug as monotherapy following this authority application, because combination treatment with ursodeoxycholic acid is not tolerated.
Patient must have received treatment with this drug for this PBS indication prior to 1 September 2021; AND
Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; OR
Patient must have experienced an intolerance to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND
Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised; AND
Patient must have had, prior to initiating treatment with this drug, an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of 'normal', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; OR
Patient must have had, prior to initiating treatment with this drug, a total bilirubin level between 1 to 2 times the ULN, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; OR
Patient must have had, prior to initiating treatment with this drug, abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid.
Patient must be aged 18 years or older.
Document and retain in the patient's medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the 'Continuing treatment' restriction.

Compliance with Authority Required procedures

[78]           Schedule 4, Part 1, after entry for Prednisolone

                           insert:

Prednisolone acetate

C6080

P6080

 

Corneal grafts

 

 

C6087

 

 

Uveitis

 

 

C6101

P6101

 

Uveitis

 

 

C10095

P10095

 

Severe eye inflammation
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye.
Patient must identify as Aboriginal or Torres Strait Islander.

 

[79]           Schedule 4, Part 1, entry for Semaglutide

                           insert as first entry:

Semaglutide

C5469

 

 

Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
The treatment must be in combination with metformin unless contraindicated or not tolerated; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 5469

[80]           Schedule 4, Part 1, entry for Tocilizumab

                   (a)        omit:

 

C9390

P9390

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
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 a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
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 to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine 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).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C12193

P12193

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
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 a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
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 to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine 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).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[81]           Schedule 4, Part 1, after entry for Varenicline

                           insert:

Vedolizumab

C12077

P12077

 

Severe Crohn disease
Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have a documented history of severe Crohn disease; AND
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2021; AND
Patient must have previously received induction treatment consisting of at least 2 doses with this drug for this condition in the intravenous form; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with this drug; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; OR
Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The authority application must include the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of most recent clinical assessment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.

Compliance with Written Authority Required procedures

 

C12078

P12078

 

Moderate to severe ulcerative colitis
Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab intravenous form continuing treatment restriction; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
Up to a maximum of 5 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Authority Required procedures

 

C12178

P12178

 

Severe Crohn disease
Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab intravenous form continuing treatment restriction; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; OR
Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
Up to a maximum of 5 repeats will be authorised.
If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone or electronically via the Online PBS Authorities system and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will immediate assessment approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

 

C12218

P12218

 

Severe Crohn disease
Balance of supply for Initial treatment, Continuing treatment or Grandfather patient - subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Grandfather treatment to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks therapy under Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

 

C12242

P12242

 

Moderate to severe ulcerative colitis
Initial treatment with subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 1 (new patient); OR
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR
Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16.
Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C12243

P12243

 

Severe Crohn disease
Initial treatment with subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 3 under Initial 1 (new patient); OR
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 3 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 3 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR
Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16.
Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C12244

P12244

 

Moderate to severe ulcerative colitis
Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2021; AND
Patient must have previously received induction treatment consisting of at least 2 doses with this drug for this condition in the intravenous form; AND
Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced non-PBS-subsidised treatment with this drug for this condition where a Mayo clinic or partial Mayo clinic baseline assessment is not available; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
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).
The authority application form must include the following:
(i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) and current Mayo clinic or partial Mayo clinic calculation sheet to demonstrate response, including the date of assessment; and
(ii) If the baseline Mayo or partial Mayo clinic calculation is not available, reason must be provided; and
(iii) the date of commencement of this drug.
The current Mayo clinic or partial Mayo clinic assessment must be no more than 4 weeks old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.

Compliance with Written Authority Required procedures

 

C12250

P12250

 

Moderate to severe ulcerative colitis
Balance of supply for Initial treatment, Continuing treatment or Grandfather patient - subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Grandfather treatment to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks therapy under Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

[82]           Schedule 5, omit entry for Fluoxetine

[83]           Schedule 5, omit entry for Metformin

[84]           Schedule 5, omit entry for Trihexyphenidyl