National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 1) (PB 1 of 2021) (Cth)

Case

PB 1 of 2021

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 1)

National Health Act 1953

________________________________________________________________________

I, THEA CONNOLLY, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated  27 January 2021

THEA CONNOLLY

Assistant Secretary

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. 1).

(2)This Instrument may also be cited as PB 1 of 2021.

  1. Commencement

This Instrument commences on 1 February 2021.

  1. Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1           Amendments

  1. Schedule 1, Part 1, entry for Ambrisentan in each of the forms: Tablet 5 mg; and Tablet 10 mg

omit from the column headed “Responsible Person” for the brand “Volibris”: GK                  substitute: ZE

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

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

a Pharmacor Amlodipine CR MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Bosentan in each of the forms: Tablet 62.5 mg (as monohydrate); and Tablet 125 mg (as monohydrate)

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

a Bosentan Cipla LR MP See Note 3 See Note 3 See Note 3 See Note 3 60 D(100)

(b)omit from the column headed “Brand”: BOSENTAN DR. REDDY'S              substitute: BOSENTAN DR.REDDY'S

  1. Schedule 1, Part 1, entry for Carfilzomib in each of the forms: Powder for injection 10 mg; Powder for injection 30 mg; and Powder for injection 60 mg

omit from the column headed “Circumstances”: C7348 C10855                   substitute: C11196 C11197 C11198 C11291

  1. Schedule 1, Part 1, entry for Clonidine in the form Tablet containing clonidine hydrochloride 100 micrograms

omit from the column headed “Responsible Person” for the brand “Catapres 100”: BY               substitute: IX

  1. Schedule 1, Part 1, entry for Clonidine in the form Tablet containing clonidine hydrochloride 150 micrograms

omit from the column headed “Responsible Person” for the brand “Catapres”: BY   substitute: IX

  1. Schedule 1, Part 1, entry for Codeine with paracetamol in the form Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg [Maximum Quantity: 10; Number of Repeats: 0]

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

a APX-Paracetamol/Codeine TY MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20

  1. Schedule 1, Part 1, entry for Codeine with paracetamol in the form Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg [Maximum Quantity: 20; Number of Repeats: 0]

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

a APX-Paracetamol/Codeine TY MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20

  1. Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg

(a)omit:

a Cyprocur 50 AS MP P5532 20
CN5532 		5
CN5532 		20

(b)omit:

a Cyprocur 50 AS MP 100 5 50

  1. Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg

omit:

a Cyprocur 100 AS MP 50 5 50

  1. Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 1]

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

Esomeprazole Mylan AL MP NP C8774 C8775 C8776 C8780 C8827 P8774 P8775 30 1 30

  1. Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

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

Esomeprazole Mylan AL MP NP C8774 C8775 C8776 C8780 C8827 P8776 P8780 P8827 30 5 30

  1. Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 1]

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

Esomeprazole Mylan AL MP NP C8777 C8778 C8902 P8902 30 1 30

  1. Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

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

Esomeprazole Mylan AL MP NP C8777 C8778 C8902 P8777 P8778 30 5 30

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

omit from the column headed “Schedule Equivalent” for all brands: a

  1. Schedule 1, Part 1, after entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

insert:

Capsule 20 mg (as hydrochloride) (USP) Oral Fluoxetine Capsule (USP) DZ MP NP C4755 C6277 28 5 100

  1. Schedule 1, Part 1, entry for Isotretinoin in each of the forms: Capsule 10 mg; and Capsule 20 mg

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

a Isotretinoin GX SZ MP C5224 60 3 60

  1. Schedule 1, Part 1, entry for Lisdexamfetamine in each of the forms: Capsule containing lisdexamfetamine dimesilate 20 mg; Capsule containing lisdexamfetamine dimesilate 30 mg; Capsule containing lisdexamfetamine dimesilate 40 mg; Capsule containing lisdexamfetamine dimesilate
    50 mg; Capsule containing lisdexamfetamine dimesilate 60 mg; and Capsule containing lisdexamfetamine dimesilate 70 mg

omit from the column headed “Circumstances”: C5252                substitute: C10792

  1. Schedule 1, Part 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg

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

a APO-Lurasidone TX MP NP C4246 30 5 30

  1. Schedule 1, Part 1, entry for Methenamine

(a)insert in the column headed “Schedule Equivalent” for the existing brand: a

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

a Uramet AS MP NP 100 5 100

  1. Schedule 1, Part 1, entry for Methylphenidate in each of the forms: Capsule containing methylphenidate hydrochloride 10 mg (modified release); Capsule containing methylphenidate hydrochloride 20 mg (modified release); Capsule containing methylphenidate hydrochloride
    30 mg (modified release); Capsule containing methylphenidate hydrochloride 40 mg (modified release); and Capsule containing methylphenidate hydrochloride 60 mg (modified release)

omit from the column headed “Circumstances”: C6298                substitute: C10719

  1. Schedule 1, Part 1, entry for Methylphenidate in each of the forms: Tablet containing methylphenidate hydrochloride 18 mg (extended release); Tablet containing methylphenidate hydrochloride 27 mg (extended release); Tablet containing methylphenidate hydrochloride 36 mg (extended release); and Tablet containing methylphenidate hydrochloride 54 mg (extended release)

omit from the column headed “Circumstances”: C6249                substitute: C10717

  1. Schedule 1, Part 1, entry for Ocriplasmin

omit:

Solution concentrate for intravitreal injection 0.5 mg in 0.2 mL Injection Jetrea IJ MP C9363 1 0 1

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

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

a Zotren 4 RF MP NP C4118 C10498 P4118 4 0 4
MP C5778 4 0 4 C(100)

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

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

a Zotren 4 RF MP NP C4118 C10498 P10498 10 1 10

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

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

a Zotren 8 RF MP NP C4118 C10498 P4118 4 0 4
MP C5778 4 0 4 C(100)

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

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

a Zotren 8 RF MP NP C4118 C10498 P10498 10 1 10

  1. Schedule 1, Part 1, entry for Oxycodone in each of the forms: Capsule containing oxycodone hydrochloride 5 mg; Capsule containing oxycodone hydrochloride 10 mg; and Capsule containing oxycodone hydrochloride 20 mg

omit from the column headed “Responsible Person” for the brand “Oxycodone BNM “ (all instances): LI                     substitute: BZ

  1. Schedule 1, Part 1, after entry for Phenelzine in the form Tablet 15 mg (as sulfate)

insert:

Tablet 15 mg (as sulfate) (USP) Oral Phenelzine sulfate USP (Generic Health) GQ MP C6236 100 1 60

  1. Schedule 1, Part 1, entry for Posaconazole

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

a Pharmacor Posaconazole CR MP NP C5169 C5395 C5396 24 0 24

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

a POSACONAZOLE DR.REDDY'S RZ MP NP C5169 C5395 C5396 24 0 24

  1. Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 5 mg [Maximum Quantity: 112; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C5918

(b)omit from the column headed “Circumstances”: C5921

(c)insert in numerical order in the column headed “Circumstances”: C11225 C11226

(d)omit from the column headed “Purposes”: P5918 P5921                 substitute: P11225 P11226

  1. Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 5 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5918

(b)omit from the column headed “Circumstances”: C5921

(c)insert in numerical order in the column headed “Circumstances”: C11225 C11226

  1. Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 10 mg [Maximum Quantity: 56; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C5918

(b)omit from the column headed “Circumstances”: C5921

(c)insert in numerical order in the column headed “Circumstances”: C11225 C11226

(d)omit from the column headed “Purposes”: P5918 P5921                 substitute: P11225 P11226

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

(a)omit from the column headed “Circumstances”: C5918

(b)omit from the column headed “Circumstances”: C5921

(c)insert in numerical order in the column headed “Circumstances”: C11225 C11226

  1. Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 15 mg [Maximum Quantity: 56; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C5918

(b)omit from the column headed “Circumstances”: C5921

(c)insert in numerical order in the column headed “Circumstances”: C11225 C11226

(d)omit from the column headed “Purposes”: P5918 P5921                 substitute: P11225 P11226

  1. Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 15 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5918

(b)omit from the column headed “Circumstances”: C5921

(c)insert in numerical order in the column headed “Circumstances”: C11225 C11226

  1. Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 20 mg [Maximum Quantity: 56; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C5918

(b)omit from the column headed “Circumstances”: C5921

(c)insert in numerical order in the column headed “Circumstances”: C11225 C11226

(d)omit from the column headed “Purposes”: P5918 P5921                 substitute: P11225 P11226

  1. Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 20 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5918

(b)omit from the column headed “Circumstances”: C5921

(c)insert in numerical order in the column headed “Circumstances”: C11225 C11226

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

insert:

Selexipag Tablet 200 micrograms Oral Uptravi JC MP C11193 C11195 C11241 C11261 P11193 P11195 P11241 60 5 60 D(100)
MP C11193 C11195 C11241 C11261 P11241 P11261 140 2 140 D(100)
Tablet 400 micrograms Oral Uptravi JC MP C11193 C11195 C11241 60 5 60 D(100)
Tablet 600 micrograms Oral Uptravi JC MP C11193 C11195 C11241 60 5 60 D(100)
Tablet 800 micrograms Oral Uptravi JC MP C11193 C11195 C11241 C11261 P11261 60 3 60 D(100)
MP C11193 C11195 C11241 C11261 P11193 P11195 P11241 60 5 60 D(100)
Tablet 1 mg Oral Uptravi JC MP C11193 C11195 C11241 60 5 60 D(100)
Tablet 1.2 mg Oral Uptravi JC MP C11193 C11195 C11241 60 5 60 D(100)
Tablet 1.4 mg Oral Uptravi JC MP C11193 C11195 C11241 60 5 60 D(100)
Tablet 1.6 mg Oral Uptravi JC MP C11193 C11195 C11241 60 5 60 D(100)

  1. Schedule 1, Part 1, entry for Sildenafil

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

a Sildenafil PHT APOTEX TY MP See Note 3 See Note 3 See Note 3 See Note 3 90 D(100)

  1. Schedule 1, Part 1, entry for Spironolactone in the form Tablet 25 mg

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

a Spironolactone Mylan 25 AL MP NP 100 5 100

  1. Schedule 1, Part 1, entry for Spironolactone in the form Tablet 100 mg

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

a Spironolactone Mylan 100 AL MP NP 100 5 100

  1. Schedule 1, Part 1, entry for Tadalafil

(a)insert in the column headed “Schedule Equivalent” for the brand “Adcirca”: a

(b)insert in the column headed “Schedule Equivalent” for the brand "Tadalca”: a

  1. Schedule 1, Part 1, after entry for Terbutaline in the form Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses

insert:

Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 120 doses Inhalation by mouth Bricanyl Turbuhaler AP MP NP C9828 2 5 1

  1. Schedule 1, Part 1, after entry for Trihexyphenidyl in the form Tablet containing trihexyphenidyl hydrochloride 2 mg

insert:

Tablet containing trihexyphenidyl hydrochloride 2 mg (USP) Oral Trihexyphenidyl hydrochloride USP (Medsurge) DZ MP NP 200 2 100

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

omit:

Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL Injection DBL Zoledronic Acid PF MP C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 1 11 1 PB(100)

  1. Schedule 1, Part 1, entry for Zoledronic acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

omit: 

a Ostira PF MP C5710 C6308 C6313 C6318 1 0 1

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

  1. Schedule 1, Part 2, entry for Cyproterone

substitute:

Cyproterone Tablet containing cyproterone acetate 50 mg Oral a Cyprostat SY MP C5532 20 5 20
a Cyprocur 50 AS MP P5532 20
CN5532 		5
CN5532 		20
MP 100 5 50
Tablet containing cyproterone acetate 100 mg Oral a Cyprocur 100 AS MP 50 5 50

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

  1. Schedule 1, Part 2, entry for Ranitidine

omit:

Tablet, effervescent, 150 mg (as hydrochloride) Oral Zantac AS MP NP 60 5 30

  1. Schedule 1, Part 2, omit entry for Tenofovir with emtricitabine and efavirenz

  1. Schedule 1, Part 2, after entry for Venlafaxine in the form Capsule (modified release) 150 mg (as hydrochloride)

insert:

Zoledronic acid Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL Injection DBL Zoledronic Acid PF MP C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 1 11 1 PB(100)
Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL Injection a Ostira PF MP C5710 C6308 C6313 C6318 1 0 1

  1. Schedule 3, details relevant to Responsible Person Code TM

omit from the column headed “Responsible Person”: Technipro Marketing Pty Ltd   substitute: Technipro PulmoMed Pty Ltd

  1. Schedule 3, after details relevant to Responsible Person code ZA

insert:

ZE Seekwell Pty Ltd 91 624 401 618

  1. Schedule 4, Part 1, entry for Carfilzomib

substitute:

Carfilzomib C11196 Multiple myeloma
Initial treatment - twice weekly treatment regimen
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a stem cell transplant; AND
Patient must not have previously received this drug for this condition; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND
Patient must not receive more than three cycles of treatment under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures - Streamlined Authority Code 11196
C11197 Multiple myeloma
Continuing treatment - twice weekly treatment regimen
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with dexamethasone; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND
Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures - Streamlined Authority Code 11197
C11198 Multiple myeloma
Initial treatment - once weekly treatment regimen
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a stem cell transplant; AND
Patient must not have previously received this drug for this condition; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND
Patient must not receive more than three cycles of treatment under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures - Streamlined Authority Code 11198
C11291 Multiple myeloma
Continuing treatment - once weekly treatment regimen
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with dexamethasone; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND
Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures - Streamlined Authority Code 11291

  1. Schedule 4, Part 1, entry for Lisdexamfetamine

substitute:

Lisdexamfetamine C10792 Attention deficit hyperactivity disorder
Patient must require continuous coverage over 12 hours; AND
The treatment must not exceed a maximum daily dose of 70 mg with this drug.
Patient must be aged between the ages of 6 and 18 years inclusive; OR
Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; OR
Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; OR
Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age.
A retrospective diagnosis of ADHD for the purposes of administering this restriction is:
(i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and
(ii) documentation in the patient's medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party, has occurred and which supports point (i) above. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Methylphenidate

(a)omit:

C6249 Attention deficit hyperactivity disorder
Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.
Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND
Patient must require continuous coverage over 12 hours. 		Compliance with Authority Required procedures
C6298 Attention deficit hyperactivity disorder
Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.
Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND
Patient must require continuous coverage over 8 hours. 		Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C10717 Attention deficit hyperactivity disorder
Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.
Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND
Patient must require continuous coverage over 12 hours; AND
The treatment must not exceed a maximum daily dose of 72 mg with this drug. 		Compliance with Authority Required procedures
C10719 Attention deficit hyperactivity disorder
Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.
Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND
Patient must require continuous coverage over 8 hours; AND
The treatment must not exceed a maximum daily dose of 80 mg with this drug. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Ruxolitinib

(a)omit:

C5918 P5918 High risk and intermediate-2 risk myelofibrosis
Initial treatment
The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. 		Compliance with Authority Required procedures

(b)omit:

C5921 P5921 Intermediate-1 risk myelofibrosis
Initial treatment
The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis; AND
Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy. 		Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C11225 P11225 Intermediate-1 risk myelofibrosis
Initial treatment
The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis; AND
Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy.
The authority application must be made in writing and must include:
(1) A completed authority prescription form; and
(2) A completed Myelofibrosis Authority Application Supporting Information Form, which includes all of the following:
a) A copy of the bone marrow biopsy report confirming diagnosis of myelofibrosis;
b) A classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS; and
c) A confirmation that the patient's disease related symptoms are resistant, refractory or intolerant to available therapy. 		Compliance with Written Authority Required procedures
C11226 P11226 High risk and intermediate-2 risk myelofibrosis
Initial treatment
The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
The authority application must be made in writing and must include:
(1) A completed authority prescription form; and
(2) A completed Myelofibrosis Authority Application Supporting Information Form, which includes all of the following:
(a) A copy of the bone marrow biopsy report confirming diagnosis of myelofibrosis; and
(b) A classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS. 		Compliance with Written Authority Required procedures

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

insert:

Selexipag C11193 P11193 Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:
(i) Hospitalisation due to worsening PAH;
(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;
(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;
(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;
(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH. 		Compliance with Authority Required procedures
C11195 P11195 Pulmonary arterial hypertension (PAH)
Initial treatment following dose titration
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
Patient must have completed the dose titration phase; AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
Select one appropriate strength (determined under the 'Initial treatment - dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalfil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function. 		Compliance with Authority Required procedures
C11241 P11241 Pulmonary arterial hypertension (PAH)
Transitioning from non-PBS subsidised to PBS-subsidised supply - 'Grandfather' treatment
Patient must have received non-PBS subsidised treatment with this drug prior to 1 February 2021; AND
Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy, prior to treatment initiation with this drug; AND
Patient must have had WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have had WHO Functional Class IV PAH at treatment initiation with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalfil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:
(i) Hospitalisation due to worsening PAH;
(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;
(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;
(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;
(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function. 		Compliance with Authority Required procedures
C11261 P11261 Pulmonary arterial hypertension (PAH)
Initial treatment - dose titration
Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalfil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function. 		Compliance with Authority Required procedures

  1. Schedule 5, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [GRP-17061]

insert in alphabetical order in the column headed “Brand”: Esomeprazole Mylan

  1. Schedule 5, entry for Esomeprazolein the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [GRP-17188]

insert in alphabetical order in the column headed “Brand”: Esomeprazole Mylan

  1. Schedule 5, after entry for Filgrastim in the form Injection 480 micrograms in 1.6 mL [GRP-23385]

insert:

Fluoxetine GRP-24550 Capsule 20 mg (as hydrochloride) Oral APO-Fluoxetine
Auscap Aspen
BTC Fluoxetine
Blooms the Chemist Fluoxetine
FLUOTEX
Fluoxetine AN
Fluoxetine APOTEX
Fluoxetine Sandoz
Fluoxetine generichealth
Fluoxetine-GA
Lovan
Prozac 20
Zactin
Capsule 20 mg (as hydrochloride) (USP) Oral Fluoxetine Capsule (USP)

  1. Schedule 5, after entry for Perindopril with indapamide in the form Tablet containing perindopril arginine 5 mg with indapamide hemihydrate
    1.25 mg [GRP-15765]

insert:

Phenelzine GRP-23097 Tablet 15 mg (as sulfate) Oral Nardil
Tablet 15 mg (as sulfate) (USP) Oral Phenelzine sulfate USP (Generic Health)

  1. Schedule 5, after entry for Tiotropium in the form Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate)
    (for use in HandiHaler) [GRP-23704]

insert:

Trihexyphenidyl GRP-24549 Tablet containing trihexyphenidyl hydrochloride 2 mg Oral Artane
Tablet containing trihexyphenidyl hydrochloride 2 mg (USP) Oral Trihexyphenidyl hydrochloride USP (Medsurge)
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