National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 6) (Cth)

PB 54 of 2022

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 6)

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           29 June 2022

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

________________________________________________________________________

1. Name of Instrument

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 6).

(2)This instrument may also be cited as PB 54 of 2022.

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 July 2022	1 July 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Note: This table relates only to the provisions of this instrument as originally made.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Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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. Schedule 1, Part 1, after entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre‑filled syringe

insert:

Injection 125 mg in 1 mL single dose autoinjector (s19A)	Injection	Orencia Clickject (Germany)	DZ	MP	C8627 C8638 C8655 C8746 C11776 C11805	P8638 P8746 P11776 P11805	4	3	4
MP	C8627 C8638 C8655 C8746 C11776 C11805	P8627 P8655	4	5	4

1. Schedule 1, Part 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 50; Number of Repeats: 0]

omit:

a GenRx Aciclovir GX MP NP C5936 C5942 P5936 50 0 50

1. Schedule 1, Part 1, entry for Aciclovir in the form Tablet 200 mg [Brand: GenRx Aciclovir; Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5936

(b)omit from the column headed “Purposes”: P5942

1. Schedule 1, Part 1, entry for Aciclovir in the form Tablet 800 mg

omit:

a GenRx Aciclovir GX MP NP C5959 C5967 35 0 35

1. Schedule 1, Part 1, entry for Alendronic acid

omit:

a Alendro Once Weekly RW MP NP C6310 C6323 C6327 4 5 4

1. Schedule 1, Part 1, after entry for Ambrisentan in the form Tablet 10 mg

insert:

Amifampridine Tablet 10 mg Oral Ruzurgi OJ MP C12979 200 5 100

1. Schedule 1, Part 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

omit:

a Rithmik 200 RW MP NP C5665 30 5 30

1. Schedule 1, Part 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besilate); and Tablet 10 mg (as besilate)

omit:

a BTC Amlodipine JB MP NP 30 5 30

1. Schedule 1, Part 1, entry for Apalutamide

omit from the column headed “Brand”: Eryland   substitute: Erlyand

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

(a)omit:

a Torvastat 10 RW MP NP 30 5 30

(b)omit:

a Torvastat 10 RW MP P7598 30 11 30

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

(a)omit:

a Torvastat 20 RW MP NP 30 5 30

(b)omit:

a Torvastat 20 RW MP P7598 30 11 30

1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium)

(a)omit:

a Torvastat 40 RW MP NP 30 5 30

(b)omit:

a Torvastat 40 RW MP P7598 30 11 30

1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium)

(a)omit:

a Torvastat 80 RW MP NP 30 5 30

(b)omit:

a Torvastat 80 RW MP P7598 30 11 30

1. Schedule 1, Part 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg

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

a NOUMED BISOPROLOL VO MP NP C5324 28 5 28

1. Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in each of the forms: Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg; Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg; and Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

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

a NOUMED CANDESARTAN/HCT VO MP NP C4374 30 5 30

1. Schedule 1, Part 1, entry for Celecoxib in the form Capsule 100 mg

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

a NOUMED CELECOXIB VO MP NP C4907 C4962 60 3 60

1. Schedule 1, Part 1, entry for Celecoxib in the form Capsule 200 mg

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

a NOUMED CELECOXIB VO MP NP C4907 C4962 30 3 30

1. Schedule 1, Part 1, entry for Dantrolene

omit:

Capsule containing dantrolene sodium hemiheptahydrate 50 mg Oral Dantrium PF MP NP C6359 100 2 100

1. Schedule 1, Part 1, entry for Dimethyl fumarate in the form Capsule (modified release) 120 mg

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

a Dimethyl Fumarate Sandoz SZ MP C10139 C10140 28 0 14

1. Schedule 1, Part 1, entry for Dimethyl fumarate in the form Capsule (modified release) 240 mg

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

a Dimethyl Fumarate Sandoz SZ MP C10139 56 5 56

1. Schedule 1, Part 1, entry for Dosulepin in the form Tablet containing dosulepin hydrochloride 75 mg

(a)omit:

a Dosulepin Mylan AL MP NP 30 2 30

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

a Dosulepin Viatris 75 AL MP NP 30 2 30

1. Schedule 1, Part 1, entry for Glimepiride in the form Tablet 3 mg

omit:

a Dimirel AV MP NP 30 5 30

1. Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 4 mg

(a)omit:

a Hydrocortisone Mylan 4 AL MP NP 50 4 50

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

a Hydrocortisone Viatris 4 AL MP NP 50 4 50

1. Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 20 mg

(a)omit:

a Hydrocortisone Mylan 20 AL MP NP 60 4 60

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

a Hydrocortisone Viatris 20 AL MP NP 60 4 60

1. Schedule 1, Part 1, after entry for Imipramine in the form Tablet containing imipramine hydrochloride 25 mg

insert:

Tablet containing imipramine hydrochloride 25 mg (s19A) Oral Imipramine (Leading) QY MP NP 50 2 100

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

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

1. Schedule 1, Part 1, entry for Lacosamide in the form Tablet 50 mg [Brand: Lacosamide Lupin; 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

1. Schedule 1, Part 1, entry for Lacosamide in each of the forms: Tablet 100 mg; Tablet 150 mg; and Tablet 200 mg [Brand: Lacosamide Lupin; Maximum Quantity: 56; Number of Repeats: 5]

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

1. Schedule 1, Part 1, entry for Lapatinib

(a)omit from the column headed “Circumstances”: C10394

(b)insert in numerical order in the column headed “Circumstances”: C13007

1. Schedule 1, Part 1, after entry for Lapatinib

insert:

Larotrectinib	Capsule 25 mg (as sulfate)	Oral	Vitrakvi	BN	MP	C12980 C12981 C12982	P12981 P12982	56	2	56
MP	C12980 C12981 C12982	P12980	56	5	56
Capsule 100 mg (as sulfate)	Oral	Vitrakvi	BN	MP	C12980 C12981 C12982	P12981 P12982	56	2	56
MP	C12980 C12981 C12982	P12980	56	5	56
Oral solution 20 mg per mL (as sulfate), 100 mL	Oral	Vitrakvi	BN	MP	C12980 C12981 C12982	P12981 P12982	1	2	1
MP	C12980 C12981 C12982	P12980	1	5	1

1. Schedule 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg

omit:

APO-Meloxicam TX MP NP C4907 C4962 30 3 30

1. 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 Mirtazapine Sandoz SZ MP NP C5650 30 5 30

1. Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)

omit:

Reladdin AF MP See Note 3 See Note 3 1 D(100)

1. Schedule 1, Part 1, entry for Pertuzumab

(a)omit from the column headed “Circumstances”: C10275

(b)insert in numerical order in the column headed “Circumstances”: C13018

1. Schedule 1, Part 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C12552 C12553 C12562 C12577

(b)insert in numerical order in the column headed “Circumstances”: C13006 C13022 C13025 C13030

1. Schedule 1, Part 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C12552 C12553 C12562 C12577

(b)insert in numerical order in the column headed “Circumstances”: C13006 C13022 C13025 C13030

(c)omit from the column headed “Purposes”: P12552 P12553 P12562 P12577                   substitute: P13006 P13022 P13025 P13030

1. Schedule 1, Part 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C12552 C12553 C12562 C12577

(b)insert in numerical order in the column headed “Circumstances”: C13006 C13022 C13025 C13030

1. Schedule 1, Part 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C12552 C12553 C12562 C12577

(b)insert in numerical order in the column headed “Circumstances”: C13006 C13022 C13025 C13030

(c)omit from the column headed “Purposes”: P12552 P12553 P12562 P12577                       substitute: P13006 P13022 P13025 P13030

1. Schedule 1, Part 1, entry for Risedronic acid in the form Tablet containing risedronate sodium 35 mg

omit:

a Risedro once a week RW MP NP C6310 C6323 C6327 4 5 4

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

substitute:

Tablet 50 mg (as succinate)	Oral	APO-Sumatriptan	TX	MP NP	C5259	4	5	2
MP NP	C5259	4	5	4
Imigran	LN	MP NP	C5259	4	5	2
MP NP	C5259	4	5	4
Iptam	AL	MP NP	C5259	4	5	2
MP NP	C5259	4	5	4
Sumatran	OW	MP NP	C5259	4	5	2
MP NP	C5259	4	5	4
Pharmacor Sumatriptan 50	CR	MP NP	C5259	4	5	4
Sumatriptan generichealth	GQ	MP NP	C5259	4	5	4
Sumatriptan Sandoz	SZ	MP NP	C5259	4	5	4

1. Schedule 1, Part 1, entry for Tacrolimus in the form Capsule 0.5 mg

(a)omit:

a TACROLIMUS APOTEX TX MP 100 3 100

(b)omit:

a TACROLIMUS APOTEX TX MP P5569 P9697 200
CN5569 CN9697 5
CN5569 CN9697 100 C(100)

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

(a)omit:

a TACROLIMUS APOTEX TX MP 100 3 100

(b)omit:

a TACROLIMUS APOTEX TX MP P5569 P9697 200
CN5569 CN9697 5
CN5569 CN9697 100 C(100)

1. Schedule 1, Part 1, entry for Tacrolimus in the form Capsule 5 mg

(a)omit:

a TACROLIMUS APOTEX TX MP 50 3 50

(b)omit:

a TACROLIMUS APOTEX TX MP P5569 P9697 100
CN5569 CN9697 5
CN5569 CN9697 50 C(100)

1. Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C11882

(b)omit from the column headed “Circumstances”: C12317

(c)insert in numerical order in the column headed “Circumstances”: C12976

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

(a)omit from the column headed “Circumstances”: C11882

(b)omit from the column headed “Circumstances”: C12317

(c)insert in numerical order in the column headed “Circumstances”: C12976

(d)omit from the column headed “Purposes”: P11882

(e)omit from the column headed “Purposes”: P12317

(f)insert in numerical order in the column headed “Purposes”: P12976

1. Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 10 mg [Maximum Quantity: 56; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C11882

(b)omit from the column headed “Circumstances”: C12317

(c)insert in numerical order in the column headed “Circumstances”: C12976

1. Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 10 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C11882

(b)omit from the column headed “Circumstances”: C12317

(c)insert in numerical order in the column headed “Circumstances”: C12976

(d)omit from the column headed “Purposes”: P11882

(e)omit from the column headed “Purposes”: P12317

(f)insert in numerical order in the column headed “Purposes”: P12976

1. Schedule 1, Part 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg

(a)omit from the column headed “Circumstances”: C10214 C10255

(b)omit from the column headed “Circumstances”: C10510

(c)insert in numerical order in the column headed “Circumstances”: C12989 C13004 C13017

1. Schedule 1, Part 1, entry for Zanubrutinib

insert in numerical order in the column headed “Circumstances”: C12999 C13008 C13020

1. Schedule 1, Part 2, omit entry for Hydroxychloroquine

1. Schedule 1, Part 2, omit entry for Palbociclib

1. Schedule 3, after details relevant for Responsible Person code OH   

insert:

OJ The Trustee for ORSPEC PHARMA UNIT TRUST 15 634 980 417

1. Schedule 3, after details relevant for Responsible Person code QS

insert:

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

1. Schedule 4, Part 1, entry for Acalabrutinib

(a)omit entry for circumstances code “C12495” and substitute:

C12495 Mantle cell lymphoma
Initial treatment
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
Patient must be untreated with Bruton’s tyrosine kinase inhibitor therapy; OR
Patient must have developed intolerance to another Bruton’s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication. Compliance with Authority Required procedures

(b)omit entry for circumstances code “C12501” and substitute:

C12501 Mantle cell lymphoma
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received treatment with this drug prior to 1 February 2022; AND
The condition must have relapsed or be refractory to at least one prior therapy prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have had a WHO performance status of 0 or 1 at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have been untreated with Bruton’s tyrosine kinase inhibitor therapy at treatment initiation with this drug; OR
Patient must have developed intolerance to another Bruton’s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication; AND
Patient must not have developed disease progression while being treated with this drug for this condition. Compliance with Authority Required procedures

1. Schedule 4, Part 1, after entry for Amantadine

insert:

Amifampridine C12979 Lambert-Eaton myasthenic syndrome (LEMS)
The condition must not be any of: (i) myasthenia gravis, (ii) Guillain-Barre syndrome.
Must be treated by a prescriber type identifying as at least one of the following: (i) a clinical immunologist, (ii) a neurologist, (iii) a medical practitioner working under the direct supervision of one of these mentioned specialists. Compliance with Authority Required procedures

1. Schedule 4, Part 1, omit entry for Hydroxychloroquine

1. Schedule 4, Part 1, entry for Ibrutinib

omit entry for circumstances code “C12495” and substitute:

C12495 P12495 Mantle cell lymphoma
Initial treatment
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
Patient must be untreated with Bruton’s tyrosine kinase inhibitor therapy; OR
Patient must have developed intolerance to another Bruton’s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication. Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Lapatinib

(a)omit:

C10394 Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The treatment must be in combination with capecitabine; AND
Patient must have received prior therapy with a taxane for at least 3 cycles; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; OR
Patient must have developed intolerance to treatment with a taxane of a severity necessitating permanent treatment withdrawal; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; OR
Patient must have experienced disease progression following treatment with trastuzumab emtansine in whom disease had relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; OR
Patient must have experienced disease relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; AND
The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) details of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH); and
(ii) date of last treatment with a taxane and total number of cycles; or
(iii) dates of treatment with trastuzumab and pertuzumab; or
(iv) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab and pertuzumab; or
(v) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C13007 Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND
The treatment must be in combination with capecitabine; AND
Patient must have received prior therapy with a taxane for at least 3 cycles; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; OR
Patient must have developed intolerance to treatment with a taxane of a severity necessitating permanent treatment withdrawal; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; OR
Patient must have experienced disease progression following treatment with trastuzumab emtansine in whom disease had relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; OR
Patient must have experienced disease relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; AND
The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(i) details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH); and
(ii) date of last treatment with a taxane and total number of cycles; or
(iii) dates of treatment with trastuzumab and pertuzumab; or
(iv) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab and pertuzumab; or
(v) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.
All reports must be documented in the patient's medical records.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, after entry for Lapatinib

insert:

Larotrectinib	C12980	P12980	Solid tumours with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion Continuing treatment Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing. The treatment must cease to be a PBS benefit upon radiographic progression; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. Where radiographic progression is observed, mark any remaining repeat prescriptions with the word 'cancelled'.	Compliance with Authority Required procedures
C12981	P12981	Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion Initial treatment The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND The condition must be a mammary analogue secretory carcinoma of the salivary gland confirmed through a pathology report from an Approved Pathology Authority (of any date); OR The condition must be a secretory breast carcinoma confirmed through a pathology report from an Approved Pathology Authority (of any date); AND The condition must be metastatic disease; OR The condition must be both: (i) locally advanced, (ii) unresectable; OR The condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition. Patient must be at least 18 years of age. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include: (a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date. (b) details of the pathology report establishing the carcinoma type (salivary gland/secretory breast carcinoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion. All reports must be documented in the patient's medical records. If the application is submitted through HPOS upload or mail, it must include: (a) a completed authority prescription form; and (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C12982	P12982	Solid tumours (of any type) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion where treatment with this drug is/was initiated in a child Initial treatment The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND The condition must be metastatic disease; OR The condition must be both: (i) locally advanced, (ii) unresectable; OR The condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition. Patient must be/have been under 18 years of age (i.e. prior to their 18 th birthday) at treatment initiation with this drug. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include: (a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date. All reports must be documented in the patient's medical records. If the application is submitted through HPOS upload or mail, it must include: (a) a completed authority prescription form; and (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Pertuzumab

(a)omit:

C10275 Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have received prior anti-HER2 therapy for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
The treatment must be in combination with trastuzumab and a taxane; AND
The treatment must not be in combination with nab-paclitaxel; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes details of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH).
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C13018 Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have received prior anti-HER2 therapy for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
The treatment must be in combination with trastuzumab and a taxane; AND
The treatment must not be in combination with nab-paclitaxel; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) must be provided at the time of application.
The pathology report must be documented in the patient's medical records.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Ponatinib

(a)omit:

C12552	P12552	Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND Patient must have failed an adequate trial of imatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority. Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as: 1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either: (i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made in writing and must include: (a) a completed authority prescription form; 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) which includes the following: (i) date and result of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) date and result of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) date and result of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and (iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, date and result(s) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. Up to a maximum of 18 months of treatment may be authorised under this initial restriction.	Compliance with Written Authority Required procedures
C12553	P12553	Chronic Myeloid Leukaemia (CML) First continuing treatment Patient must have received initial 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 have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals. First continuing applications for authorisation must be in writing and must include: (a) a completed authority prescription form; 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) which includes the following: (i) major cytogenetic response (date and result) [see Note explaining definitions of response]; or (ii) a peripheral blood level of BCR-ABL of less than 1% on the international scale (date and result) [see Note explaining definitions of response].	Compliance with Written Authority Required procedures
C12562	P12562	Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal; OR Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis. Failure of an adequate trial of dasatinib or nilotinib is defined as: 1. Lack of response to dasatinib or nilotinib therapy, defined as either: (i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made in writing and must include: (a) a completed authority prescription form; 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) which includes the following: (i) date and result of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) date and result of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) where there has been a loss of response to dasatinib or nilotinib, date and result(s) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. Up to a maximum of 18 months of treatment may be authorised under this initial restriction.	Compliance with Written Authority Required procedures
C12577	P12577	Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have maintained a major cytogenic response of less than 35% Philadelphia positive bone marrow cells at 12 month intervals; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% on the international scale at 12 month intervals.	Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C13006	P13006	Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have maintained a major cytogenic response of less than 35% Philadelphia positive bone marrow cells at 12 month intervals; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% on the international scale at 12 month intervals. A pathology report demonstrating the patient's cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient's medical records.	Compliance with Authority Required procedures
C13022	P13022	Chronic Myeloid Leukaemia (CML) First continuing treatment Patient must have received initial 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 have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals. The first continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or (ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response]. All reports must be documented in the patient's medical records. If the application is submitted through HPOS upload or mail, it must include: (i) a completed authority prescription form; and (ii) 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)	Compliance with Written Authority Required procedures
C13025	P13025	Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal; OR Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis. Failure of an adequate trial of dasatinib or nilotinib is defined as: 1. Lack of response to dasatinib or nilotinib therapy, defined as either: (i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) where there has been a loss of response to dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. All reports must be documented in the patient's medical records If the application is submitted through HPOS upload or mail, it must include: (i) a completed authority prescription form; and (ii) 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) Up to a maximum of 18 months of treatment may be authorised under this initial restriction.	Compliance with Written Authority Required procedures
C13030	P13030	Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND Patient must have failed an adequate trial of imatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority. Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as: 1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either: (i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and (iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. All reports must be documented in the patient's medical records. If the application is submitted through HPOS upload or mail, it must include: (i) a completed authority prescription form; and (ii) 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) Up to a maximum of 18 months of treatment may be authorised under this initial restriction.	Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Tofacitinib

(a)omit:

C11882 P11882 Moderate to severe ulcerative colitis
Continuing treatment or Grandfathered patients - 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 Continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Compliance with Authority Required procedures

(b)omit:

C12317 P12317 Moderate to severe ulcerative colitis
Initial treatment - Grandfather 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 non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2021; AND
Patient must be receiving treatment with this drug for this condition at the time of application; 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 not receive more than 24 weeks of treatment under this restriction.
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), which includes:
(i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) including the date of assessment;
(ii) the date of commencement of this drug.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
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.
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. Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C12976 P12976 Moderate to severe ulcerative colitis
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 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

1. Schedule 4, Part 1, entry for Trastuzumab emtansine

(a)omit:

C10214	Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course for this PBS indication.	Compliance with Authority Required procedures
C10255	Early HER2 positive breast cancer Initial adjuvant treatment The treatment must be prescribed within 12 weeks after surgery; AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes details from the pathology report from an approved pathology authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.	Compliance with Written Authority Required procedures

(b)omit:

C10510 Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) details of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease;
(ii) dates of treatment with trastuzumab and pertuzumab; and
(iii) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or
(iv) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C12989	Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; 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 not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. The following information must be provided by the prescriber at the time of application: (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH). (b) dates of treatment with trastuzumab and pertuzumab; (c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or (d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. All reports must be documented in the patient's medical records. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.	Compliance with Authority Required procedures
C13004	Early HER2 positive breast cancer Initial adjuvant treatment The treatment must be prescribed within 12 weeks after surgery; AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery. The pathology report must be documented in the patient's medical records. If the application is submitted through HPOS upload or mail, it must include: (i) a completed authority prescription form; and (ii) 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)	Compliance with Written Authority Required procedures
C13017	Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course for this PBS indication.	Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Zanubrutinib

(a)omit entry for circumstances code “C12495” and substitute:

C12495 Mantle cell lymphoma
Initial treatment
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
Patient must be untreated with Bruton’s tyrosine kinase inhibitor therapy; OR
Patient must have developed intolerance to another Bruton’s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication. Compliance with Authority Required procedures

(b)omit entry for circumstances code “C12573” and substitute:

C12573 Mantle cell lymphoma
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received treatment with this drug prior to 1 March 2022; AND
The condition must have relapsed or be refractory to at least one prior therapy prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have had a WHO performance status of 0 or 1 at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have been untreated with Bruton’s tyrosine kinase inhibitor therapy at treatment initiation with this drug; OR
Patient must have developed intolerance to another Bruton’s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication; AND
Patient must not have developed disease progression while being treated with this drug for this condition. Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C12999	Waldenstrom macroglobulinaemia Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C13008	Waldenstrom macroglobulinaemia Initial treatment The condition must have relapsed or be refractory to at least one prior chemo-immunotherapy; OR Patient must be unsuitable for treatment with chemo-immunotherapy, defined by a Cumulative Illness Rating Scale of 6 or greater, if untreated (i.e. treatment-naive) for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND Patient must be untreated with a Bruton's tyrosine kinase inhibitor for this condition; OR Patient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this condition.	Compliance with Authority Required procedures
C13020	Waldenstrom macroglobulinaemia Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2022; AND The condition must have relapsed or been refractory to at least one prior chemo-immunotherapy, prior to having initiated non-PBS-subsidised treatment with this drug for this condition; OR Patient must have been unsuitable for treatment with chemo-immunotherapy, defined by a Cumulative Illness Rating Scale of 6 or greater, if untreated (i.e. treatment-naive) for this condition prior to initiating non-PBS-subsidised treatment with this drug; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition; AND Patient must have been untreated with a Bruton's tyrosine kinase inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug; OR Patient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when non-PBS-subsidised treatment was initiated for this condition.	Compliance with Authority Required procedures

1. Schedule 5, after entry for Abacavir with lamivudine

insert:

Abatacept	GRP-26370	Injection 125 mg in 1 mL single dose autoinjector	Injection	Orencia ClickJect
Injection 125 mg in 1 mL single dose autoinjector (s19A)	Injection	Orencia Clickject (Germany)

1. Schedule 5, after entry for Imatinib

insert:

Imipramine	GRP-24222	Tablet containing imipramine hydrochloride 25 mg	Oral	Tofranil 25
Tablet containing imipramine hydrochloride 25 mg (s19A)	Oral	Imipramine (Leading)

1. Schedule 5, entry for Meloxicam in the form Tablet 15 mg [GRP-15468]

omit from the column headed “Brand”: APO-Meloxicam

1. Schedule 5, entry for Meloxicam in the form Tablet 7.5 mg [GRP-15658]

omit from the column headed “Brand”: APO-Meloxicam

1. Schedule 5, omit entry for Palbociclib