National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 10) (PB 102 of 2020) (Cth)

Case

PB 102 of 2020

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020
(No. 10)

National Health Act 1953

________________________________________________________________________

I, PAUL HANSEN, Assistant Secretary (Acting), 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                  29 October 2020

PAUL HANSEN

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

  1. Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 10).

(2)This Instrument may also be cited as PB 102 of 2020.

  1. Commencement

This Instrument commences on 1 November 2020.

  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, entry for Amisulpride in the form Tablet 100 mg

omit:

a Pharmacor Amisulpride CR MP NP C4246 30 5 30

  1. Schedule 1, entry for Amisulpride in each of the forms: Tablet 200 mg; and Tablet 400 mg

omit:

a Pharmacor Amisulpride CR MP NP C4246 60 5 60

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

omit:

a Pharmacor Amlodipine CR MP NP 30 5 30

  1. Schedule 1, entry for Amoxicillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1;
    Number of Repeats: 0]

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

a NOUMED AMOXICILLIN VO PDP 1 0 1

  1. Schedule 1, entry for Amoxicillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1;
    Number of Repeats: 1]

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

a NOUMED AMOXICILLIN VO MP NP 1 1 1

  1. Schedule 1, entry for Amoxicillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1;
    Number of Repeats: 0]

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

a NOUMED AMOXICILLIN VO PDP 1 0 1

  1. Schedule 1, entry for Amoxicillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1;
    Number of Repeats: 1]

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

a NOUMED AMOXICILLIN VO MP NP 1 1 1

  1. Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

(a)omit:

a Clavam 875 mg/125 mg CR MP NP C5832 C5893 C10413 P5832 P5893 10 0 10
PDP C5833 C5894 10 0 10

(b)omit:

a Clavam 875 mg/125 mg CR MP NP C5832 C5893 C10413 P10413 20 0 10

  1. Schedule 1, entry for Armodafinil in each of the forms: Tablet 50 mg; Tablet 150 mg; and Tablet 250 mg

omit from the column headed “Circumstances”: C6547 C8694                     substitute: C10935 C10967 C10970

  1. Schedule 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 840 mg in 14 mL

insert in numerical order in the column headed “Circumstances”: C10915 C10972

  1. Schedule 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 1200 mg in 20 mL

insert in numerical order in the column headed “Circumstances”: C10915 C10917 C10939

  1. Schedule 1, omit entry for Aurothiomalate

  1. Schedule 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in 16 mL

insert in numerical order in the column headed “Circumstances”: C10959

  1. Schedule 1, entry for Codeine in the form Tablet containing codeine phosphate hemihydrate 30 mg [Authorised Prescriber: MP NP; Maximum Quantity: 10; Number of Repeats: 0]

omit from the column headed “Circumstances”: C10479

  1. Schedule 1, entry for Codeine in the form Tablet containing codeine phosphate hemihydrate 30 mg [Authorised Prescriber: MP NP; Maximum Quantity: 20; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C10479

(b)omit from the column headed “Purposes”: P10479

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

omit:

a Cyprostat SY MP P5532 20
CN5532 		5
CN5532 		20

  1. Schedule 1, entry for Darunavir

omit:

Tablet 150 mg (as ethanolate) Oral Prezista JC MP NP C5094 240 5 240 D(100)

  1. Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C10180 C10189

(b)insert in numerical order in the column headed “Circumstances”: C10933 C10978

  1. Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C10180 C10189

(b)insert in numerical order in the column headed “Circumstances”: C10933 C10978

(c)omit from the column headed “Purposes”: P10180 P10189

(d)insert in numerical order in the column headed “Purposes”: P10933 P10978

  1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

(a)omit:

a Pharmacor Diclofenac 50 CR PDP C6256 C6282 50 0 50

(b)omit:

a Pharmacor Diclofenac 50 CR MP NP C6149 C6214 C6283 50 3 50

  1. Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg

(a)omit:

a Pharmacor Donepezil 10 CR MP C10099 C10100 C10107 C10108 C10110 P10107 P10110 28 1 28

(b)omit:

a Pharmacor Donepezil 10 CR MP C10099 C10100 C10107 C10108 C10110 P10099 P10100 P10108 28 5 28
NP C10108 28 5 28

  1. Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit:

a Pharmacor Escitalopram 10 CR MP NP C4755 28 5 28

  1. Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit:

a Pharmacor Escitalopram 20 CR MP NP C4755 28 5 28

  1. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate)

(a)omit:

Pharmacor Esomeprazole CR MP NP C8774 C8775 C8776 C8780 C8827 P8774 P8775 30 1 30

(b)omit:

Pharmacor Esomeprazole CR MP NP C8774 C8775 C8776 C8780 C8827 P8776 P8780 P8827 30 5 30

  1. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate)

(a)omit:

Pharmacor Esomeprazole CR MP NP C8777 C8778 C8902 P8902 30 1 30

(b)omit:

Pharmacor Esomeprazole CR MP NP C8777 C8778 C8902 P8777 P8778 30 5 30

  1. Schedule 1, entry for Famciclovir in the form Tablet 250 mg

(a)omit:

a Famciclovir SCP 250 CR MP NP C5951 C5971 P5951 21 0 21

(b)omit:

a Famciclovir SCP 250 CR MP NP C5951 C5971 P5971 56 5 56

  1. Schedule 1, entry for Flucloxacillin

omit:

Capsule 250 mg (as sodium) Oral Medsurge DZ PDP C5298 24 0 28
MP NP MW C5414 24 0 28

  1. Schedule 1, entry for Flucloxacillin in the form Capsule 250 mg (as sodium monohydrate)

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

  1. Schedule 1, entry for Flucloxacillin

omit:

Capsule 500 mg (as sodium) Oral Medsurge DZ PDP C5298 24 0 100
MP C5414 C6169 P5414 24 0 100
NP MW C5414 24 0 100
MP C5414 C6169 P6169 48 1 100

  1. Schedule 1, entry for Flucloxacillin in the form Capsule 500 mg (as sodium monohydrate)

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

  1. Schedule 1, entry for Glyceryl trinitrate

omit:

Tablets 600 micrograms, 100 Buccal/sublingual a Anginine Stabilised RW PDP 1 0 1
a Lycinate RF PDP 1 0 1
a Anginine Stabilised RW MP NP 1 5 1
a Lycinate RF MP NP 1 5 1

  1. Schedule 1, entry for Glycomacropeptide and essential amino acid formula with vitamins, minerals, and low in tyrosine and phenylalanine

insert as first entry:

Sachets containing oral powder 31 g, 30 (Tylactin Build 20) Oral Tylactin Build 20 QH MP NP C5533 4 5 1

  1. Schedule 1, entry for IncobotulinumtoxinA

omit from the column headed “Responsible Person”: EZ             substitute: EJ

  1. Schedule 1, entry for Ketoconazole

omit:

Shampoo 10 mg per g, 100 mL Application Nizoral 1% JT MP NP C6434 1 1 1

  1. Schedule 1, omit entry for Lenograstim

  1. Schedule 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8593

(b)insert in numerical order in the column headed “Circumstances”: C10991

  1. Schedule 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 90; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8593

(b)insert in numerical order in the column headed “Circumstances”: C10991

(c)omit from the column headed “Purposes”: P8593

(d)insert in numerical order in the column headed “Purposes”: P10991

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

insert:

Methoxsalen Solution for blood fraction 20 microgram per mL, 10 mL Extracorporeal circulation Uvadex TQ MP C10971 C10985 C10988 C10989 P10988 P10989 1 5 12 D(100)
MP C10971 C10985 C10988 C10989 P10971 P10985 2 6 12 D(100)

  1. Schedule 1, entry for Modafinil

omit from the column headed “Circumstances” (all instances): C6547 C8694             substitute: C10935 C10968 C10970

  1. Schedule 1, entry for Nifedipine

omit:

Tablet 20 mg (controlled release) Oral Adalat Oros 20mg BN MP NP 30 5 30

  1. Schedule 1, entry for Olaparib in the form Capsule 50 mg

omit from the column headed “Circumstances”: C6705 C6715 C6716   substitute: C10937

  1. Schedule 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8169 C8171 C8188 C10615 C10634 C10642   substitute: C10913 C10914 C10937 C10958

(b)omit from the column headed “Purposes”: P10615 P10634 P10642                substitute: P10914 P10958

  1. Schedule 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8169 C8171 C8188 C10615 C10634 C10642   substitute: C10913 C10914 C10937 C10958

(b)omit from the column headed “Purposes”: P8169 P8171 P8188                       substitute: P10913 P10937

  1. Schedule 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8169 C8171 C8188 C10615 C10634 C10642   substitute: C10913 C10914 C10937 C10958

(b)omit from the column headed “Purposes”: P10615 P10634 P10642                substitute: P10914 P10958

  1. Schedule 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8169 C8171 C8188 C10615 C10634 C10642   substitute: C10913 C10914 C10937 C10958

(b)omit from the column headed “Purposes”: P8169 P8171 P8188                    substitute: P10913 P10937

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

(a)omit:

Pharmacor Omeprazole CR MP NP C8774 C8775 C8776 C8780 C8866 P8774 P8775 30 1 30

(b)omit:

Pharmacor Omeprazole CR MP NP C8774 C8775 C8776 C8780 C8866 P8776 P8780 P8866 30 5 30

  1. Schedule 1, entry for Oxaliplatin

omit:

Solution concentrate for I.V. infusion 50 mg in 10 mL Injection Oxaliplatin SUN RA MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Periciazine

(a)omit:

Tablet 2.5 mg, 84 Oral Neulactil SW MP NP 84 5 84

(b)omit:

Tablet 10 mg, 84 Oral Neulactil SW MP NP 84 5 84

  1. Schedule 1, entry for Phenoxybenzamine

omit:

Capsule containing 10 mg phenoxybenzamine hydrochloride Oral Dibenzyline BZ MP NP C6145 C6178 100 5 100

  1. Schedule 1, entry for Pioglitazone in each of the forms: Tablet 30 mg (as hydrochloride); and Tablet 45 mg (as hydrochloride)

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

a NOUMED PIOGLITAZONE VO MP NP C4363 C4364 C4388 28 5 28

  1. Schedule 1, omit entry for Pneumococcal vaccine - polyvalent

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

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

a Quetiapine Sandoz Pharma HX MP NP C7893 C7916 C7927 60 0 60

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

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

a Quetiapine Sandoz Pharma HX MP NP C4246 C5611 C5639 90 5 90

  1. Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

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

a Quetiapine Sandoz Pharma HX MP NP C4246 C5611 C5639 60 5 60

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

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

a Quetiapine Sandoz Pharma HX MP NP C4246 C5611 C5639 60 5 60

  1. Schedule 1, entry for Quinagolide

omit:

Pack containing 3 tablets quinagolide 25 micrograms (as hydrochloride) and 3 tablets quinagolide 50 micrograms (as hydrochloride) Oral Norprolac FP MP C5136 C5137 C5357 C5398 1 0 1

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg

(a)omit:

a Rispericor 0.5 CR MP NP C5903 C6898 C6899 C10020 C10021 P6898 P6899 P10020 P10021 60 2 60

(b)omit:

a Rispericor 0.5 CR MP NP C5903 C6898 C6899 C10020 C10021 P5903 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg 

(a)omit:

a Rispericor 1 CR MP NP C4246 C5907 C6898 C6899 C10020 C10021 P6898 P6899 P10020 P10021 60 2 60

(b)omit:

a Rispericor 1 CR MP NP C4246 C5907 C6898 C6899 C10020 C10021 P4246 P5907 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg

(a)omit:

a Rispericor 2 CR MP NP C4246 C5907 C6897 C6938 P6897 P6938 60 2 60

(b)omit:

a Rispericor 2 CR MP NP C4246 C5907 C6897 C6938 P4246 P5907 60 5 60

  1. Schedule 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

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

Asmol CFC-Free with dose counter AF MP NP 2 5 1

  1. Schedule 1, after entry for Simvastatin in the form Tablet 80 mg

insert:

Siponimod Tablet 250 micrograms (as hemifumarate) Oral Mayzent NV MP C10953 C10955 C10956 12 0 12
MP C10953 C10955 C10956 120 5 120
Tablet 2 mg (as hemifumarate) Oral Mayzent NV MP C10953 C10955 C10956 28 5 28

  1. Schedule 1, omit entry for Sofosbuvir

  1. Schedule 1, entry for Sorafenib in the form Tablet 200 mg (as tosilate) [Maximum Quantity: 120; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8616

(b)insert in numerical order in the column headed “Circumstances”: C10960

(c)omit from the column headed “Purposes”: P8616

(d)insert in numerical order in the column headed “Purposes”: P10960

  1. Schedule 1, entry for Sorafenib in the form Tablet 200 mg (as tosilate) [Maximum Quantity: 120; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8616

(b)insert in numerical order in the column headed “Circumstances”: C10960

  1. Schedule 1, entry for Topotecan

omit from the column headed “Circumstances”: C6238

  1. Schedule 1, after entry for Topotecan in the form Powder for I.V. infusion 4 mg (as hydrochloride)

insert:

Solution concentrate for I.V. infusion 4 mg in 4 mL (as hydrochloride) Injection Topotecan Accord OC MP See Note 3 See Note 3 5 D(100)

  1. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

(a)omit:

a Tramadol SCP CR MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20

(b)omit:

a Tramadol SCP CR MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20

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

insert:

EJ Encapsulate Pharma Pty Ltd 80 640 718 289

  1. Schedule 3

omit:

EZ Merz Australia Pty Ltd 62 151 073 559

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

insert:

TQ Terumo BCT Australia Pty Limited 87 130 046 865

  1. Schedule 4, Part 1, entry for Alemtuzumab

substitute:

Alemtuzumab C6847 P6847 Multiple sclerosis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must not receive more than one PBS-subsidised treatment per year; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist. 		Compliance with Authority Required procedures - Streamlined Authority Code 6847
C7714 P7714 Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7714
C9589 P9589 Multiple sclerosis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must not receive more than one PBS-subsidised treatment per year; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist. 		Compliance with Authority Required procedures - Streamlined Authority Code 9589
C9636 P9636 Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 9636

  1. Schedule 4, Part 1, entry for Armodafinil

substitute:

Armodafinil C10935 Narcolepsy
Initial 2 - treatment of narcolepsy with cataplexy
Must be treated by a qualified sleep medicine practitioner or neurologist.
The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; OR
The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND
Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND
Patient must have a definite history of cataplexy documented in their medical records for auditing purposes; AND
Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.
The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:
(a) a psychiatric disorder;
(b) a cardiovascular disorder;
(c) a history of substance abuse;
(d) glaucoma;
(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information. 		Compliance with Authority Required procedures
C10967 Narcolepsy
Continuing or change of treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have previously received PBS-subsidised treatment with modafinil for this condition. 		Compliance with Authority Required procedures
C10970 Narcolepsy
Initial 1 - treatment of narcolepsy without cataplexy
Must be treated by a qualified sleep medicine practitioner or neurologist.
The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; OR
The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND
Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND
Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); OR
Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND
Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.
The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:
(a) a psychiatric disorder;
(b) a cardiovascular disorder;
(c) a history of substance abuse;
(d) glaucoma;
(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.
The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.
The authority application must be made in writing and must include the following:
(a) a completed authority prescription form; and
(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and
(c) details of the contraindication or intolerance to dexamfetamine sulfate; and
(d) either:
(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or
(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.
The polysomnography, MSLT or EEG test reports must be provided with the authority application. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Atezolizumab

insert in numerical order after existing text:

C10915 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Transitioning from non-PBS-subsidised to PBS-subsidised supply - Grandfather treatment - 3 weekly treatment regimen (1,200 mg) or 4 weekly treatment regimen (1,680 mg where bevacizumab is discontinued)
Patient must have commenced non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 November 2020; AND
Patient must have met all the PBS eligibility criteria applying to a non-grandfather patient under the Initial treatment restriction for this PBS indication prior to having commenced non-PBS-subsidised treatment with this drug, which are: (i) WHO status score no greater than 1, (ii) Child Pugh class A chronic liver disease, (iii) the patient was unsuitable for transarterial chemoembolization, (iv) the condition was untreated with systemic therapy, unless an intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal had occurred; AND
Patient must not have developed disease progression while being treated with this drug for this condition.
Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria. 		Compliance with Authority Required procedures - Streamlined Authority Code 10915
C10917 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Continuing treatment of hepatocellular carcinoma - 3 weekly treatment regimen
Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.
PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time 		Compliance with Authority Required procedures - Streamlined Authority Code 10917
C10939 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Initial treatment
Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated.
Patient must have a WHO performance status of 0 or 1; AND
Patient must not be suitable for transarterial chemoembolisation; AND
Patient must have Child Pugh class A; AND
The condition must be untreated with systemic therapy; OR
Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal. 		Compliance with Authority Required procedures - Streamlined Authority Code 10939
C10972 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Continuing treatment where bevacizumab is discontinued - 4 weekly treatment regimen
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.
PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time 		Compliance with Authority Required procedures - Streamlined Authority Code 10972

  1. Schedule 4, Part 1, entry for Bevacizumab

insert in numerical order after existing text:

C10959 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Concurrent use with atezolizumab in hepatocellular carcinoma
Patient must be undergoing combination treatment with PBS-subsidised atezolizumab for this PBS indication. 		Compliance with Authority Required procedures - Streamlined Authority Code 10959

  1. Schedule 4, Part 1, entry for Cladribine

(a)omit entry for Circumstances Code “C10170” and substitute:

C10170 Relapsing remitting multiple sclerosis
Initial treatment
The condition must be diagnosed by a neurologist; AND
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
The prescriber should write authority prescriptions for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. 		Compliance with Authority Required procedures - Streamlined Authority Code 10170

(b)omit entry for Circumstances Code “C10171” and substitute:

C10171 Relapsing remitting multiple sclerosis
Continuing treatment
Must be treated by a neurologist.
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate, this therapy.
The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. 		Compliance with Authority Required procedures - Streamlined Authority Code 10171

  1. Schedule 4, Part 1, entry for Codeine

omit:

C10479 P10479 Cough
The treatment must be for cough suppression.

  1. Schedule 4, Part 1, entry for Dexamethasone

(a)omit:

C10180 P10180 Diabetic macular oedema (DMO)
Initial treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye; AND
Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR
Patient must be unsuitable for treatment with VEGF inhibitors; OR
Patient must have failed prior treatment with VEGF inhibitors; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. 		Compliance with Written Authority Required procedures
C10189 P10189 Diabetic macular oedema (DMO)
Continuing treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye; AND
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C10933 P10933 Diabetic macular oedema (DMO)
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye; AND
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures
C10978 P10978 Diabetic macular oedema (DMO)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye; AND
Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR
Patient must be unsuitable for treatment with VEGF inhibitors; OR
Patient must have failed prior treatment with VEGF inhibitors; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Dimethyl fumarate

substitute:

Dimethyl fumarate C10139 Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 10139
C10140 Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 10140

  1. Schedule 4, Part 1, entry for Fingolimod

substitute:

Fingolimod C10093 Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Patient must weigh 40 kg or less. 		Compliance with Authority Required procedures - Streamlined Authority Code 10093
C10162 Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 10162
C10172 Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy. 		Compliance with Authority Required procedures - Streamlined Authority Code 10172
C10198 Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Patient must weigh 40 kg or less.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 10198

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

  1. Schedule 4, Part 1, entry for Lenvatinib

(a)omit:

C8593 P8593 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not be suitable for transarterial chemoembolisation; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have Child Pugh class A; AND
Patient must not have received prior treatment with a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) for this condition; OR
Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal. 		Compliance with Authority Required procedures - Streamlined Authority Code 8593

(b)insert in numerical order after existing text:

C10991 P10991 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not be suitable for transarterial chemoembolisation; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have Child Pugh class A; AND
The condition must be untreated with systemic therapy; OR
Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal. 		Compliance with Authority Required procedures - Streamlined Authority Code 10991

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

insert:

Methoxsalen C10971 P10971 Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma
Initial treatment
Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; OR
Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Patient must be aged 18 years or over. 		Compliance with Authority Required procedures - Streamlined Authority Code 10971
C10985 P10985 Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma
Initial treatment
Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; OR
Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Patient must be aged 18 years or over. 		Compliance with Authority Required procedures - Streamlined Authority Code 10985
C10988 P10988 Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma
Continuing treatment
Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND
Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment 		Compliance with Authority Required procedures - Streamlined Authority Code 10988
C10989 P10989 Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma
Continuing treatment
Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND
Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment 		Compliance with Authority Required procedures - Streamlined Authority Code 10989

  1. Schedule 4, Part 1, entry for Modafinil

substitute:

Modafinil C10935 Narcolepsy
Initial 2 - treatment of narcolepsy with cataplexy
Must be treated by a qualified sleep medicine practitioner or neurologist.
The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; OR
The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND
Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND
Patient must have a definite history of cataplexy documented in their medical records for auditing purposes; AND
Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.
The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:
(a) a psychiatric disorder;
(b) a cardiovascular disorder;
(c) a history of substance abuse;
(d) glaucoma;
(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information. 		Compliance with Authority Required procedures
C10968 Narcolepsy
Continuing or change of treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have previously received PBS-subsidised treatment with armodafinil for this condition. 		Compliance with Authority Required procedures
C10970 Narcolepsy
Initial 1 - treatment of narcolepsy without cataplexy
Must be treated by a qualified sleep medicine practitioner or neurologist.
The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; OR
The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND
Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND
Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); OR
Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND
Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.
The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:
(a) a psychiatric disorder;
(b) a cardiovascular disorder;
(c) a history of substance abuse;
(d) glaucoma;
(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.
The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.
The authority application must be made in writing and must include the following:
(a) a completed authority prescription form; and
(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and
(c) details of the contraindication or intolerance to dexamfetamine sulfate; and
(d) either:
(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or
(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.
The polysomnography, MSLT or EEG test reports must be provided with the authority application. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Natalizumab

substitute:

Natalizumab C9744 Clinically definite relapsing-remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program. 		Compliance with Authority Required procedures - Streamlined Authority Code 9744
C9818 Clinically definite relapsing-remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program. 		Compliance with Authority Required procedures - Streamlined Authority Code 9818

  1. Schedule 4, Part 1, entry for Ocrelizumab

substitute:

Ocrelizumab C7386 Multiple sclerosis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist. 		Compliance with Authority Required procedures - Streamlined Authority Code 7386
C7699 Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7699
C9523 Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 9523
C9635 Multiple sclerosis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist. 		Compliance with Authority Required procedures - Streamlined Authority Code 9635

  1. Schedule 4, Part 1, entry for Olaparib

substitute:

Olaparib C10913 P10913 High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Continuing treatment - first line treatment
Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response. 		Compliance with Authority Required procedures
C10914 P10914 High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment - first line treatment
The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing. 		Compliance with Authority Required procedures
C10937 P10937 High grade epithelial ovarian, fallopian tube or primary peritoneal cancer
Continuing treatment - second line treatment
Patient must have previously received PBS-subsidised treatment with this drug as a second line therapy for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be maintenance therapy; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. 		Compliance with Authority Required procedures - Streamlined Authority Code 10937
C10958 P10958 High grade epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment - second line treatment
The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
The condition must be platinum sensitive; AND
Patient must have received at least two previous platinum-containing regimens; AND
Patient must have relapsed following a previous platinum-containing regimen; AND
Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be maintenance therapy; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.
A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Pneumococcal vaccine - polyvalent

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

insert:

Siponimod C10953 Multiple sclerosis
Continuing treatment (including recommencement of treatment)
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must be ambulatory, with/without assistance/support; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy. 		Compliance with Authority Required procedures - Streamlined Authority Code 10953
C10955 Multiple sclerosis
Initial treatment
The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; OR
The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory, with/without assistance/support; AND
Patient must have mild disability in at least 3 functional systems; OR
Patient must have moderate disability in at least 1 functional system.
Functional systems referred to in this restriction are the: visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems.
Select a dose and pack size appropriate for the patient's CYP2C9 metabolising enzyme status. 		Compliance with Authority Required procedures - Streamlined Authority Code 10955
C10956 Multiple sclerosis
Grandfather treatment (transition from non-PBS-subsidised to PBS-subsidised treatment)
Patient must have commenced non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 November 2020; AND
The condition must have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
The condition must have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have mild disability in at least 3 functional systems prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have moderate disability in at least 1 functional system prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must be ambulatory, with/without assistance/support; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Functional systems referred to in this restriction are the: visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. 		Compliance with Authority Required procedures - Streamlined Authority Code 10956

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

  1. Schedule 4, Part 1, entry for Sorafenib

(a)omit:

C8616 P8616 Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have Child Pugh class A; AND
Patient must not have received prior treatment with a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) for this condition; OR
Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal. 		Compliance with Authority Required procedures - Streamlined Authority Code 8616

(b)insert in numerical order after existing text:

C10960 P10960 Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have Child Pugh class A; AND
The condition must be untreated with systemic therapy; OR
Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal. 		Compliance with Authority Required procedures - Streamlined Authority Code 10960

  1. Schedule 4, Part 1, entry for Teriflunomide

substitute:

Teriflunomide C10150 Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 10150
C10199 Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 10199

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

  1. Schedule 4, Part 3 - General statement for drugs for the treatment of hepatitis C

substitute:

Part 3—General statement for drugs for the treatment of hepatitis C

1        Criteria for eligibility for drugs for the treatment of chronic hepatitis C

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

(1)the patient has been assessed in accordance with paragraph 2 of this Part; and

(2)the patient is:

(a)treated by a medical practitioner or an authorised nurse practitioner who is experienced in the treatment of patients with chronic hepatitis C infection; or

(b)treated by a medical practitioner or an authorised nurse practitioner in consultation with:

(i)a gastroenterologist; or

(ii)a hepatologist; or

(iii)an infectious diseases physician.

2        Assessment of patient

For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:

(1)documented the following information in the patient’s medical records:

(a)evidence of chronic hepatitis C infection; and

(b)where possible, evidence of the patient’s hepatitis C virus genotype; and

(2)chosen a regimen in accordance with paragraph 3 of this Part; and

(3)collected the following information for the purposes of the authority application:

(a)whether the patient is:

(i)cirrhotic; or

(ii)non-cirrhotic

(b)details of the previous treatment regimen (only for requests for sofosbuvir with velpatasvir and voxilaprevir or glecaprevir with pibrentasvir for 16 weeks’ treatment in patients who have previously failed a treatment with a regimen containing an NS5A inhibitor).

(4)In this paragraph, evidence of chronic hepatitis C infection is documentation of:

(a)repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and

(b)test result showing hepatitis C virus ribonucleic acid (RNA) positive.

3        Treatment regimen

For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:

(1)is a kind of patient mentioned for an Item in column 2 of the following table; and

(2)is to receive one of the regimens mentioned in column 3 of the same Item of the following table.

Item Kind of patient Regimen
1

Patient:

(a)    all genotypes (pan-genotypic); and

(b)    who is treatment naïve; and

(c)    who is non-cirrhotic.

Either:

(a)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)    GLECAPREVIR with PIBRENTASVIR for 8 weeks.
2

Patient:

(a)    all genotypes (pan-genotypic); and

(b)    who is treatment experienced; and

(c)    who is non-cirrhotic.

Either:

(a)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)    SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or

(c)    GLECAPREVIR with PIBRENTASVIR for 8 weeks; or

(d)    GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(e)    GLECAPREVIR with PIBRENTASVIR 16 weeks.
3

Patient:

(a)    with Genotype 1; and

(b)    who is treatment naïve; and

(c)    who is non-cirrhotic.

Either:

(a)    LEDIPASVIR with SOFOSBUVIR for 8 weeks; or

(b)    LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(c)    GRAZOPREVIR with ELBASVIR for 12 weeks.
4

Patient:

(a)    with Genotype 1; and

(b)    who is treatment experienced; and

(c)    who is non-cirrhotic.

Either:

(a)    LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)    GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)    GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
5

Patient:

(a)    with Genotype 2; and

(b)    who is treatment naïve; and

(c)    who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
6

Patient:

(a)    with Genotype 2; and

(b)    who is treatment experienced; and

(c)    who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
7

Patient:

(a)    with Genotype 3; and

(b)    who is treatment naïve; and

(c)    who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
8

Patient:

(a)    with Genotype 3; and

(b)    who is treatment experienced; and

(c)    who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
9

Patient:

(a)    with Genotype 4; and

(b)    who is treatment naïve; and

(c)    who is non-cirrhotic.

 GRAZOPREVIR with ELBASVIR for 12 weeks.
10

Patient:

(a)    with Genotype 4; and

(b)    who is treatment experienced; and

(c)    who is non-cirrhotic.

Either:

(a)    GRAZOPREVIR with ELBASVIR for 12 weeks; or

(b)    GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
11

Patient:

(a)    with:

                (i)       Genotype 5; or

               (ii)       Genotype 6; and

(b)    who is treatment naïve; and

(c)    who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
12

Patient:

(a)    with:

                (i)       Genotype 5; or

               (ii)       Genotype 6; and

(b)    who is treatment experienced; and

(c)    who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
13

Patient:

(a)    all genotypes (pan-genotypic); and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

Either:

(a)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)    GLECAPREVIR with PIBRENTASVIR for 12 weeks.
14

Patient:

(a)    all genotypes (pan-genotypic); and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

Either:

(a)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)    SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or

(c)    GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(d)    GLECAPREVIR with PIBRENTASVIR 16 weeks.
15

Patient:

(a)    with Genotype 1; and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

Either:

(a)    LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)    GRAZOPREVIR with ELBASVIR for 12 weeks.
16

Patient:

(a)    with Genotype 1; and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

Either:

(a)    LEDIPASVIR with SOFOSBUVIR for 24 weeks; or

(b)    GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)    GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
17

Patient:

(a)    with Genotype 2; and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
18

Patient:

(a)    with Genotype 2; and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
19

Patient:

(a)    with Genotype 3; and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
20

Patient:

(a)    with Genotype 3; and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
21

Patient:

(a)    with Genotype 4; and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

 GRAZOPREVIR with ELBASVIR for 12 weeks.
22

Patient:

(a)    with Genotype 4; and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

Either:

(a)    GRAZOPREVIR with ELBASVIR for 12 weeks; or

(b)    GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
23

Patient:

(a)    with:

                (i)       Genotype 5; or

               (ii)       Genotype 6; and

(b)    who is treatment naïve; and

(c)    who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
24

Patient:

(a)    with:

                (i)       Genotype 5; or

               (ii)       Genotype 6; and

(b)    who is treatment experienced; and

(c)    who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).

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

omit from the column headed “Brand”: Pharmacor Esomeprazole

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

omit from the column headed “Brand”: Pharmacor Esomeprazole

  1. Schedule 5, omit entry for Flucloxacillin

  1. Schedule 5, entry for Omeprazole in the form Tablet 20 mg [GRP-14650]

omit from the column headed “Brand”: Pharmacor Omeprazole

  1. Schedule 5, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) [GRP-24211]

insert in alphabetical order in the column headed “Brand”: Asmol CFC-Free with dose counter

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