National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 12) (Cth)

PB 128 of 2021

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 12)

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 17 December 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. 12).

(2)This instrument may also be cited as PB 128 of 2021.

1. 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 January 2022	1 January 2022

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

1. Authority

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

1. 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Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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. Subsection 10A(3)

omit: 1 January 2022        substitute: 1 July 2022

1. Schedule 1, Part 1, entry for Acalabrutinib 

(a)omit from the column headed “Circumstances”: C10668

(b)insert in numerical order in the column headed “Circumstances”: C12481

1. Schedule 1, Part 1, entry for Arsenic

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

Arsenic Trioxide-AFT AE MP C4793 C5997 C6018 See Note 3 See Note 3 10 D(100)

1. Schedule 1, Part 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride); Capsule
   25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); and Capsule 60 mg (as hydrochloride)

omit:

a ATOMERRA RW MP C7876 C7890 56 5 28

1. Schedule 1, Part 1, entry for Atomoxetine in each of the forms: Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)

omit:

a ATOMERRA RW MP C7876 C7890 28 5 28

1. Schedule 1, Part 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)

(a)omit:

a Cefaclor GH GQ PDP 10 0 10

(b)omit:

a Cefaclor GH GQ MP 10 1 10

1. Schedule 1, Part 1, entry for Cetuximab in each of the forms: Solution for I.V. infusion 100 mg in 20 mL; and Solution for I.V. infusion 500 mg in 100 mL

insert in numerical order in the column headed “Circumstances”: C12470 C12483

1. Schedule 1, Part 1, entry for Dapagliflozin

insert in numerical order the column headed “Circumstances”(all instances): C12477

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 2]

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

a Deferasirox Sandoz SZ MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7385 P8326 P8328 P8329 P9222 P9258 P9302 180 2 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 5]

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

a Deferasirox Sandoz SZ MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7374 P7375 180 5 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 2]

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

a Deferasirox Sandoz SZ MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7385 P8326 P8328 P8329 P9222 P9258 P9302 180 2 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 5]

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

a Deferasirox Sandoz SZ MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7374 P7375 180 5 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 2]

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

a Deferasirox Sandoz SZ MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7385 P8326 P8328 P8329 P9222 P9258 P9302 180 2 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 5]

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

a Deferasirox Sandoz SZ MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7374 P7375 180 5 30 D(100)

1. Schedule 1, Part 1, entry for Encorafenib in the form Capsule 75 mg

substitute:

Capsule 75 mg	Oral	Braftovi	FB	MP	C6013 C10271 C12484 C12487	P12487	126	3	42
MP	C6013 C10271 C12484 C12487	P12484	126	5	42
MP	C6013 C10271 C12484 C12487	P10271	168	3	42
MP	C6013 C10271 C12484 C12487	P6013	168	5	42

1. Schedule 1, Part 1, entry for Ibrutinib in the form Capsule 140 mg [Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C10647

(b)insert in numerical order in the column headed “Circumstances”: C12472

(c)omit from the column headed “Purposes”: P10647

(d)insert in numerical order in the column headed “Purposes”: P12472

1. Schedule 1, Part 1, entry for Ibrutinib in the form Capsule 140 mg [Maximum Quantity: 120; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C10647

(b)insert in numerical order in the column headed “Circumstances”: C12472

1. Schedule 1, Part 1, entry for Idelalisib in each of the forms: Tablet 100 mg; and Tablet 150 mg

omit from the column headed “Circumstances”: C7052 C7053 C7387 C7388 substitute: C12479 C12480 C12490 C12491

1. Schedule 1, Part 1, entry for Imipramine

omit:

Tablet containing imipramine hydrochloride 10 mg USP Oral Imipramine (Leading) QY MP NP 50 2 100

1. Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 4; Number of Repeats: 0]

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

Ondansetron ODT Lupin	HQ	MP NP	C5618 C10498	P5618	4	0	4
MP	C5743	4	0	4	C(100)

1. Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

Ondansetron ODT Lupin HQ MP NP C5618 C10498 P10498 10 1 10

1. Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 4; Number of Repeats: 0]

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

Ondansetron ODT Lupin	HQ	MP NP	C5618 C10498	P5618	4	0	4
MP	C5743	4	0	4	C(100)

1. Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

Ondansetron ODT Lupin HQ MP NP C5618 C10498 P10498 10 1 10

1. Schedule 1, Part 1, entry for Palbociclib

substitute:

Palbociclib	Tablet 75 mg	Oral	Ibrance	PF	MP	C10015 C10735	21	5	21
Tablet 100 mg	Oral	Ibrance	PF	MP	C10015 C10735	21	5	21
Tablet 125 mg	Oral	Ibrance	PF	MP	C10015 C10735	21	5	21

1. Schedule 1, Part 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg 

(a)omit:

a Pravastatin generichealth GQ MP NP 30 5 30

(b)omit:

a Pravastatin generichealth GQ MP P7598 30 11 30

1. Schedule 1, Part 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

omit:

a Quetiapine GH 25 GQ MP NP C7893 C7916 C7927 60 0 60

1. Schedule 1, Part 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

omit:

a Quetiapine GH 100 GQ MP NP C4246 C5611 C5639 90 5 90

1. Schedule 1, Part 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

omit:

a Quetiapine GH 300 GQ MP NP C4246 C5611 C5639 60 5 60

1. Schedule 1, Part 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)

omit:

a Acquin Aspen 5 RW MP NP 30 5 30

1. Schedule 1, Part 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)

omit:

a Acquin Aspen 10 RW MP NP 30 5 30

1. Schedule 1, Part 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)

omit:

a Acquin Aspen 20 RW MP NP 30 5 30

1. Schedule 1, Part 1, entry for Romosozumab

(a)omit from the column headed “Circumstances”: C11487

(b)insert in numerical order in the column headed “Circumstances”: C12475

1. Schedule 1, Part 1, entry for Rosuvastatin in each of the forms: Tablet 5 mg (as calcium); Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); and Tablet 40 mg (as calcium)

(a)omit:

a Rosuvastatin generichealth HQ MP NP 30 5 30

(b)omit:

a Rosuvastatin generichealth HQ MP P7598 30 11 30

1. Schedule 1, Part 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

(a)insert in numerical order in the column headed “Circumstances” for the brand “APO-Sertraline”: C6277 C6289

(b)insert in numerical order in the column headed “Circumstances” for the brand “Sertra 50”: C6277 C6289

(c)insert in numerical order in the column headed “Circumstances” for the brand “Sertraline Sandoz”: C6277 C6289

1. Schedule 1, Part 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)

(a)insert in numerical order in the column headed “Circumstances” for the brand “APO-Sertraline”: C6277 C6289

(b)insert in numerical order in the column headed “Circumstances” for the brand “Sertra 100”: C6277 C6289

(c)insert in numerical order in the column headed “Circumstances” for the brand “Sertraline Sandoz”: C6277 C6289

1. Schedule 1, Part 1, entry for Teriparatide in the form Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge

(a)omit from the column headed “Circumstances”: C12269

(b)insert in numerical order in the column headed “Circumstances”: C12492

1. Schedule 1, Part 1, entry for Teriparatide

omit:

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen Injection Forteo LY MP C11464 C11486 1 5 1

1. Schedule 1, Part 1, omit entry for Tipranavir

1. Schedule 1, Part 1, entry for Venetoclax in the form Pack containing 14 tablets venetoclax 10 mg and 7 tablets venetoclax 50 mg and 7 tablets venetoclax 100 mg and 14 tablets venetoclax 100 mg

(a)omit from the column headed “Circumstances”: C8607

(b)insert in numerical order in the column headed “Circumstances”: C12482

1. Schedule 1, Part 2, after entry for Exenatide

insert:

Palbociclib	Capsule 75 mg	Oral	Ibrance	PF	MP	C10015 C10735	21	5	21
Capsule 100 mg	Oral	Ibrance	PF	MP	C10015 C10735	21	5	21
Capsule 125 mg	Oral	Ibrance	PF	MP	C10015 C10735	21	5	21

1. Schedule 1, Part 2, after entry for Terbutaline

insert:

Teriparatide Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen Injection Forteo LY MP C11464 C11486 1 5 1

1. Schedule 1, Part 2, after entry for Testosterone

insert:

Tipranavir Capsule 250 mg Oral Aptivus BY MP NP C5764 240 5 120 D(100)

1. Schedule 3

omit:

QY Pro Pharmaceuticals Group Pty. Ltd. 20 605 457 430

1. Schedule 4, Part 1, entry for Acalabrutinib

(a)omit:

C10668 Relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue; AND
Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease); OR
Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by a Medical Benefits Schedule listed test. Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C12481 Relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue; AND
Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease); OR
Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by a Medicare Benefits Schedule listed test. Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Cetuximab

insert in numerical order after existing text:

C12470	P12470	Metastatic colorectal cancer Continuing treatment The treatment must be in combination with PBS-subsidised encorafenib for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 12470
C12483	P12483	Metastatic colorectal cancer Initial treatment The treatment must be in combination with PBS-subsidised encorafenib for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 12483

1. Schedule 4, Part 1, entry for Dapagliflozin

insert in numerical order after existing text:

C12477 Chronic heart failure
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. Compliance with Authority Required procedures - Streamlined Authority Code 12477

1. Schedule 4, Part 1, entry for Encorafenib

insert in numerical order after existing text:

C12484	P12484	Metastatic colorectal cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with cetuximab; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 12484
C12487	P12487	Metastatic colorectal cancer Initial treatment Patient must have BRAF V600 variant positive metastatic colorectal cancer; AND The treatment must be in combination with cetuximab; AND Patient must not have received prior treatment with cetuximab for this condition; OR Patient must not have developed disease progression while receiving cetuximab for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must have failed to respond to at least one other line of systemic therapy; AND Patient must have a WHO performance status of 2 or less.	Compliance with Authority Required procedures - Streamlined Authority Code 12487

1. Schedule 4, Part 1, entry for Ibrutinib

(a)omit:

C10647 P10647 Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease); OR
Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH). Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C12472 P12472 Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease); OR
Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by a Medicare Benefits Schedule listed test. Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Idelalisib

substitute:

Idelalisib	C12479	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment The condition must be confirmed Chronic lymphocytic leukaemia (CLL) prior to initiation of treatment; OR The condition must be confirmed Small lymphocytic lymphoma (SLL) prior to initiation of treatment; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with rituximab for up to a maximum of 8 doses under this restriction, followed by monotherapy for this condition; AND The condition must have relapsed or be refractory to at least one prior therapy; AND The condition must be CD20 positive; AND Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); AND Patient must be inappropriate for chemo-immunotherapy. The prescriber must provide the CIRS score at the time of application. A patient can be considered inappropriate for chemo-immunotherapy when one or more of the following are experienced: 1. Severe neutropenia defined as absolute neutrophil count of less than or equal to 1.0 x 109/L; or 2. Severe thrombocytopenia defined as platelet count of less than or equal to 50 x 109/L; or 3. Evidence of one or more 17p chromosomal deletions demonstrated by a Medicare Benefits Schedule listed test. A pathology report confirming the patient is inappropriate for chemo-immunotherapy must be documented in the patient's medical records and must be no more than 4 weeks old at the time of application.	Compliance with Authority Required procedures
C12480	Refractory follicular B-cell non-Hodgkin's lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 12480
C12490	Refractory follicular B-cell non-Hodgkin's lymphoma Initial treatment The condition must be refractory to a prior therapy with rituximab within 6 months after completion of treatment with rituximab; AND The condition must be refractory to a prior therapy with an alkylating agent within 6 months after completion of treatment with an alkylating agent; AND The treatment must be the sole PBS-subsidised therapy for this condition. The condition is considered refractory to a prior therapy when the patient experiences less than a partial response or progression of disease within 6 months after completion of the prior therapy. The condition is considered refractory to both rituximab and an alkylating agent if the agents were administered together or in successive treatment regimens. The date of completion of prior therapies with rituximab and an alkylating agent must be documented in the patient's medical records.	Compliance with Authority Required procedures
C12491	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for Chronic lymphocytic leukaemia; OR Patient must have previously received PBS-subsidised treatment with this drug for Small lymphocytic leukaemia; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Romosozumab

(a)omit:

C11487 Severe established osteoporosis
Initial treatment
Patient must be at very high risk of fracture; AND
Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND
Patient must have had 2 or more fractures due to minimal trauma; AND
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a lifetime maximum of 12 months therapy; AND
Patient must not have received treatment with teriparatide; OR
Patient must have developed intolerance to teriparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.
Must be treated by a specialist; OR
Must be treated by a consultant physician.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated.
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated.
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.
Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application. Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C12475 Severe established osteoporosis
Initial treatment
Patient must be at very high risk of fracture; AND
Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND
Patient must have had 2 or more fractures due to minimal trauma; AND
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a lifetime maximum of 12 months therapy; AND
Patient must not have received treatment with PBS-subsidised teriparatide; OR
Patient must have developed intolerance to teriparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.
Must be treated by a specialist; OR
Must be treated by a consultant physician.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated.
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated.
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.
Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application. Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Teriparatide

(a)omit:

C12269 Severe established osteoporosis
Initial treatment
Must be treated by a specialist; OR
Must be treated by a consultant physician.
Patient must be at very high risk of fracture; AND
Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND
Patient must have had 2 or more fractures due to minimal trauma; AND
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a lifetime maximum of 18 months therapy; AND
Patient must not have received treatment with romosozumab; OR
Patient must have developed intolerance to romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.
Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be documented in the patient's medical record. Compliance with Authority Required procedures - Streamlined Authority Code 12269

(b)insert in numerical order after existing text:

C12492 Severe established osteoporosis
Initial treatment
Must be treated by a specialist; OR
Must be treated by a consultant physician.
Patient must be at very high risk of fracture; AND
Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND
Patient must have had 2 or more fractures due to minimal trauma; AND
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a lifetime maximum of 18 months therapy; AND
Patient must not have received treatment with PBS-subsidised romosozumab; OR
Patient must have developed intolerance to romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.
Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be documented in the patient's medical record. Compliance with Authority Required procedures - Streamlined Authority Code 12492

1. Schedule 4, Part 1, entry for Venetoclax

(a)omit:

C8607 Chronic lymphocytic leukaemia (CLL)
Initial treatment - Dose titration
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be used as monotherapy for this condition under this restriction.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH). Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C12482 Chronic lymphocytic leukaemia (CLL)
Initial treatment - Dose titration
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be used as monotherapy for this condition under this restriction.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by a Medicare Benefits Schedule listed test. Compliance with Authority Required procedures

1. Schedule 5, omit entry for Imipramine

1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [GRP-15402]

insert in alphabetical order in the column headed “Brand”: Ondansetron ODT Lupin

1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [GRP-15983]

insert in alphabetical order in the column headed “Brand”: Ondansetron ODT Lupin

1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [GRP-16933]    

insert in alphabetical order in the column headed “Brand”: Ondansetron ODT Lupin

1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [GRP-17042]   

insert in alphabetical order in the column headed “Brand”: Ondansetron ODT Lupin

1. Schedule 6, entry for Adalimumab

substitute:

Adalimumab	Injection 20 mg in 0.2 mL pre-filled syringe	Injection
Adalimumab	Injection 20 mg in 0.4 mL pre‑filled syringe	Injection
Adalimumab	Injection 40 mg in 0.4 mL pre-filled pen	Injection
Adalimumab	Injection 40 mg in 0.4 mL pre-filled syringe	Injection
Adalimumab	Injection 40 mg in 0.8 mL pre‑filled syringe	Injection
Adalimumab	Injection 40 mg in 0.8 mL pre‑filled pen	Injection
Adalimumab	Injection 80 mg in 0.8 mL pre-filled pen	Injection
Adalimumab	Injection 80 mg in 0.8 mL pre-filled syringe	Injection

1. Schedule 6, entry for Vedolizumab

substitute:

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