National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 9) (PB 89 of 2020) (Cth)

Case

PB 89 of 2020

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 9)

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                  28 September 2020

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 2020 (No. 9).

(2)This Instrument may also be cited as PB 89 of 2020.

  1. Commencement

This Instrument commences on 1 October 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 Acarbose in the form Tablet 50 mg

omit:

a Glucobay 50 BN MP NP 90 5 90

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 4 [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6971 C6972

(b)insert in numerical order in the column headed “Circumstances”: C10838

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 4 [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6971 C6972

(b)insert in numerical order in the column headed “Circumstances”: C10838

(c)omit from the column headed “Purposes”: P6971 P6972                 substitute: P10838

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6

(a)omit from the column headed “Circumstances”: C6951

(b)insert in numerical order in the column headed “Circumstances”: C10892

  1. Schedule 1, entry for Aflibercept

insert as first entry:

Solution for intravitreal injection 3.6 mg in 90 microlitres (40 mg per mL) pre-filled syringe Injection Eylea BN MP C10708 C10715 C10716 C10783 C10789 C10818 C10826 C10827 C10862 C10911 P10708 P10715 P10783 P10789 P10818 P10827 P10862 P10911 1 2 1
MP C10708 C10715 C10716 C10783 C10789 C10818 C10826 C10827 C10862 C10911 P10716 P10826 1 5 1

  1. Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7517 C7536 C7553 C7564 C7570 C7571 C7587 C7592 substitute: C10708 C10715 C10716 C10783 C10789 C10818 C10826 C10827 C10862 C10911

(b)omit from the column headed “Purposes”: P7536 P7564 P7570 P7571 P7587 P7592                   substitute: P10708 P10715 P10783 P10789 P10818 P10827 P10862 P10911

  1. Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7517 C7536 C7553 C7564 C7570 C7571 C7587 C7592 substitute: C10708 C10715 C10716 C10783 C10789 C10818 C10826 C10827 C10862 C10911

(b)omit from the column headed “Purposes”: P7517 P7553                 substitute: P10716 P10826

  1. Schedule 1, entry for Alectinib

omit from the column headed “Circumstances”: C7353

  1. Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

omit:

a Dronalen Plus AL MP NP C6306 C6319 C6325 4 5 4

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Sachets containing oral powder 27.8 g, 30 (PKU Lophlex)

insert:

Sachets containing oral powder 28 g, 30 (PKU Lophlex) Oral PKU Lophlex SB MP NP C4295 4 5 1

  1. Schedule 1, entry for Apomorphine

substitute:

Apomorphine Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL Injection Movapo TD MP C4833 C9561 360 5 5 PB(100)
Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL Injection Movapo TD MP C4833 C9561 180 5 5 PB(100)
Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL Injection Apomine Solution for Infusion PF MP NP C10844 90 5 5
MP C10830 C10863 90 5 5 C(100)
Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe Injection Movapo PFS TD MP C4833 C9561 180 5 5 PB(100)
Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen Injection a Apomine Intermittent PF MP NP C10844 100 5 5
MP C10830 C10863 100 5 5 C(100)
a Movapo Pen TD MP NP C10844 100 5 5
MP C10830 C10863 100 5 5 C(100)

  1. Schedule 1, entry for Brentuximab vedotin

(a)omit from the column headed “Circumstances”: C6903 C6936

(b)insert in numerical order in the column headed “Circumstances”: C10811 C10902

  1. Schedule 1, entry for Buprenorphine

substitute:

Buprenorphine Injection (modified release) 8 mg in 0.16 mL pre-filled syringe Injection Buvidal Weekly UR MP NP C9212 See Note 3 See Note 3 1 PB(100)
Injection (modified release) 16 mg in 0.32 mL pre-filled syringe Injection Buvidal Weekly UR MP NP C9212 See Note 3 See Note 3 1 PB(100)
Injection (modified release) 24 mg in 0.48 mL pre-filled syringe Injection Buvidal Weekly UR MP NP C9212 See Note 3 See Note 3 1 PB(100)
Injection (modified release) 32 mg in 0.64 mL pre-filled syringe Injection Buvidal Weekly UR MP NP C9212 See Note 3 See Note 3 1 PB(100)
Injection (modified release) 64 mg in 0.18 mL pre-filled syringe Injection Buvidal Monthly UR MP NP C9212 See Note 3 See Note 3 1 PB(100)
Injection (modified release) 96 mg in 0.27 mL pre-filled syringe Injection Buvidal Monthly UR MP NP C9212 See Note 3 See Note 3 1 PB(100)
Injection (modified release) 100 mg in 0.5 mL pre-filled syringe Injection Sublocade IR MP NP C9212 See Note 3 See Note 3 1 PB(100)
Injection (modified release) 128 mg in 0.36 mL pre-filled syringe Injection Buvidal Monthly UR MP NP C9212 See Note 3 See Note 3 1 PB(100)
Injection (modified release) 300 mg in 1.5 mL pre-filled syringe Injection Sublocade IR MP NP C9212 See Note 3 See Note 3 1 PB(100)
Transdermal patch 5 mg Transdermal a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Buprenorphine Sandoz SZ MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
Transdermal patch 10 mg Transdermal a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Buprenorphine Sandoz SZ MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
Transdermal patch 15 mg Transdermal a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Buprenorphine Sandoz SZ MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
Transdermal patch 20 mg Transdermal a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Buprenorphine Sandoz SZ MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
Transdermal patch 25 mg Transdermal a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
Transdermal patch 30 mg Transdermal a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
Transdermal patch 40 mg Transdermal a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
a Norspan MF MP NP C6151 C10748 C10752 C10755 P6151 4 2 2
Tablet (sublingual) 400 micrograms (as hydrochloride) Sublingual Subutex IR MP NP C6451 See Note 3 See Note 3 7 PB(100)
Tablet (sublingual) 2 mg (as hydrochloride) Sublingual Subutex IR MP NP C6451 See Note 3 See Note 3 7 PB(100)
Tablet (sublingual) 8 mg (as hydrochloride) Sublingual Subutex IR MP NP C6451 See Note 3 See Note 3 7 PB(100)

  1. Schedule 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

(a)omit from the column headed “Circumstances”: C7344

(b)omit from the column headed “Circumstances”: C7355

(c)insert in numerical order in the column headed “Circumstances”: C10855

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

omit from the column headed “Circumstances” (all instances): C10123

  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]

(a)omit from the column headed “Circumstances”: C10442 C10444

(b)insert in numerical order in the column headed “Circumstances”: C10764 C10766 C10771 C10772

(c)omit from the column headed “Purposes”: P10442   substitute: P10766

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

(a)omit from the column headed “Circumstances”: C10442 C10446                     substitute: C10766 C10768

(b)omit from the column headed “Purposes”: P10442   substitute: P10766

  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”: C10442 C10444

(b)insert in numerical order in the column headed “Circumstances”: C10764 C10766 C10771 C10772

(c)omit from the column headed “Purposes”: P10444

(d)insert in numerical order in the column headed “Purposes”: P10764 P10771 P10772

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

(a)omit from the column headed “Circumstances”: C10442 C10446                     substitute: C10766 C10768

(b)omit from the column headed “Purposes”: P10446   substitute: P10768

  1. Schedule 1, entry for Codeine with paracetamol

substitute:

Codeine with paracetamol Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg Oral a APO- Paracetamol/Codeine 500/30 TX MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Codalgin Forte AF MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Codapane Forte 500/30 AL MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Comfarol Forte SZ MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Panadeine Forte SW MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Paracetamol/Codeine GH 500/30 GQ MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Prodeine Forte AV MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a APO- Paracetamol/Codeine 500/30 TX MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Codalgin Forte AF MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Codapane Forte 500/30 AL MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Comfarol Forte SZ MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Panadeine Forte SW MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Paracetamol/Codeine GH 500/30 GQ MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Prodeine Forte AV MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20

  1. Schedule 1, omit entry for Daclatasvir

  1. Schedule 1, omit entry for Danazol

  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”: C8020 C8023 C8032 C8033

(b)insert in numerical order in the column headed “Circumstances”: C10713 C10822 C10861 C10904

  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”: C8020 C8023 C8032 C8033

(b)insert in numerical order in the column headed “Circumstances”: C10713 C10822 C10861 C10904

(c)omit from the column headed “Purposes”: P8020 P8023 P8032 P8033

(d)insert in numerical order in the column headed “Purposes”: P10713 P10822 P10861 P10904

  1. Schedule 1, entry for Dexamethasone

omit:

Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL Injection Dexamethasone Mylan AF MP NP 5 0 5
Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL Injection Dexamethasone Mylan AF MP NP 5 1 5

  1. Schedule 1, omit entry for Dipyridamole

  1. Schedule 1, entry for Dipyridamole with aspirin

(a)        omit:

a Asasantin SR BY MP NP C6424 60 5 60

(b)      omit from the column headed “Schedule Equivalent” for the brand “Diasp SR”: a

  1. Schedule 1, entry for Disopyramide

omit from the column headed “Responsible Person”: SW           substitute: PB

  1. Schedule 1, entry for Fentanyl in the form Transdermal patch 1.28 mg

omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 2.063 mg; and Transdermal patch 2.1 mg

omit from the column headed “Circumstances” (all instances): C10441                      substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Fentanyl in the form Transdermal patch 2.55 mg

omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 4.125 mg; and Transdermal patch 4.2 mg

omit from the column headed “Circumstances” (all instances): C10441                       substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 5.10 mg; and Transdermal patch 7.65 mg

omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 8.25 mg; and Transdermal patch 8.4 mg

omit from the column headed “Circumstances” (all instances): C10441                       substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Fentanyl in the form Transdermal patch 10.20 mg

omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 12.375 mg; Transdermal patch 12.6 mg; Transdermal patch 16.5 mg; and Transdermal patch 16.8 mg

omit from the column headed “Circumstances” (all instances): C10441                       substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Gefitinib

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

a Cipla Gefitinib LR MP C4473 C7447 30 3 30

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

  1. Schedule 1, entry for Guselkumab

(a)omit from the column headed “Circumstances”: C8496

(b)omit from the column headed “Circumstances”: C8909 C8938 C8957 C8958 C8976 C8977 C9903 C9996 C10322 C10327

(c)insert in numerical order in the column headed “Circumstances: C10742 C10743 C10806 C10807 C10810 C10875 C10889 C10900 C10901

  1. Schedule 1, entry for Hydromorphone

substitute:

Hydromorphone Injection containing hydromorphone hydrochloride 2 mg in 1 mL Injection a Dilaudid MF MP NP C10764 C10770 C10777 5 0 5
a HYDROMORPHONE JUNO JU MP NP C10764 C10770 C10777 5 0 5
a MEDSURGE HYDROMORPHONE 2 mg/1 mL DZ MP NP C10764 C10770 C10777 5 0 5
Injection containing hydromorphone hydrochloride 10 mg in 1 mL Injection a Dilaudid-HP MF MP NP C10764 C10770 C10777 5 0 5
a HYDROMORPHONE JUNO-HP JU MP NP C10764 C10770 C10777 5 0 5
a MEDSURGE HYDROMORPHONE HP 10 mg/1 mL DZ MP NP C10764 C10770 C10777 5 0 5
Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 200 mL Oral Dilaudid MF MP NP C10764 C10770 C10777 1 0 1
PDP C10859 1 0 1
Tablet containing hydromorphone hydrochloride 2 mg Oral Dilaudid MF MP NP C10758 C10764 C10770 C10777 P10758 10 0 20
PDP C10758 C10859 P10758 10 0 20
MP NP C10758 C10764 C10770 C10777 P10764 P10770 P10777 20 0 20
PDP C10758 C10859 P10859 20 0 20
Tablet containing hydromorphone hydrochloride 4 mg Oral Dilaudid MF MP NP C10758 C10764 C10770 C10777 P10758 10 0 20
PDP C10758 C10859 P10758 10 0 20
MP NP C10758 C10764 C10770 C10777 P10764 P10770 P10777 20 0 20
PDP C10758 C10859 P10859 20 0 20
Tablet containing hydromorphone hydrochloride 8 mg Oral Dilaudid MF MP NP C10758 C10764 C10770 C10777 P10758 10 0 20
PDP C10758 C10859 P10758 10 0 20
MP NP C10758 C10764 C10770 C10777 P10764 P10770 P10777 20 0 20
PDP C10758 C10859 P10859 20 0 20
Tablet (modified release) containing hydromorphone hydrochloride 4 mg Oral Jurnista JC MP NP C10752 C10753 C10754 14 0 14
Tablet (modified release) containing hydromorphone hydrochloride 8 mg Oral Jurnista JC MP NP C10752 C10753 C10754 14 0 14
Tablet (modified release) containing hydromorphone hydrochloride 16 mg Oral Jurnista JC MP NP C10752 C10753 C10754 14 0 14
Tablet (modified release) containing hydromorphone hydrochloride 32 mg Oral Jurnista JC MP NP C10752 C10753 C10754 14 0 14
Tablet (modified release) containing hydromorphone hydrochloride 64 mg Oral Jurnista JC MP NP C10752 C10753 C10754 14 0 14

  1. Schedule 1, entry for Hydroxycarbamide

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

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

a HYDROXYCARBAMIDE MEDSURGE DZ MP 100 3 100

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

omit from the column headed “Circumstances”: C7806

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

(a)omit from the column headed “Circumstances”: C7806

(b)omit from the column headed “Purposes”: P7806

  1. Schedule 1, entry for Icatibant

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

Cipla Icatibant LR MP C7273 C7274 1 1 1

(b)       omit:

Firazyr TK MP C7273 C7274 1 1 1

  1. Schedule 1, entry for Inotuzumab ozogamicin

omit from the column headed “Circumstances”: C9600

  1. Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL

omit from the column headed “Circumstances”: C8569

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

omit from the column headed “Circumstances”: C8618

  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”: C8618

(b)omit from the column headed “Purposes”: P8618

  1. Schedule 1, entry for Levodopa with carbidopa and entacapone in each of the forms: Tablet 50 mg-12.5 mg (as monohydrate)-200 mg; Tablet 75 mg-18.75 mg (as monohydrate)-200 mg; and Tablet 100 mg-25 mg (as monohydrate)-200 mg

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

a Carlevent TX MP NP C5212 C5288 200 4 100

  1. Schedule 1, entry for Levodopa with carbidopa and entacapone in each of the forms: Tablet 125 mg-31.25 mg (as monohydrate)-200 mg; Tablet 150 mg-37.5 mg (as monohydrate)-200 mg; and Tablet 200 mg-50 mg (as monohydrate)-200 mg

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

a Carlevent TX MP NP C5212 C5288 200 4 100

  1. Schedule 1, entry for Methadone in the form Injection containing methadone hydrochloride 10 mg in 1 mL

omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Methadone in the form Tablet containing methadone hydrochloride 10 mg

omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

omit:

a Remeron SolTab AF MP NP C5650 30 5 30

  1. Schedule 1, entry for Morphine

substitute:

Morphine Capsule containing morphine sulfate pentahydrate 10 mg (containing sustained release pellets) Oral Kapanol YN MP NP C9248 C10748 C10752 C10755 28 0 28
Capsule containing morphine sulfate pentahydrate 20 mg (containing sustained release pellets) Oral Kapanol YN MP NP C9248 C10748 C10752 C10755 28 0 28
Capsule containing morphine sulfate pentahydrate 30 mg (controlled release) Oral MS Mono MF MP NP C10748 C10752 C10755 14 0 14
Capsule containing morphine sulfate pentahydrate 50 mg (containing sustained release pellets) Oral Kapanol YN MP NP C10748 C10752 C10755 28 0 28
Capsule containing morphine sulfate pentahydrate 60 mg (controlled release) Oral MS Mono MF MP NP C10748 C10752 C10755 14 0 14
Capsule containing morphine sulfate pentahydrate 90 mg (controlled release) Oral MS Mono MF MP NP C10748 C10752 C10755 14 0 14
Capsule containing morphine sulfate pentahydrate 100 mg (containing sustained release pellets) Oral Kapanol YN MP NP C10748 C10752 C10755 28 0 28
Capsule containing morphine sulfate pentahydrate 120 mg (controlled release) Oral MS Mono MF MP NP C10748 C10752 C10755 14 0 14
Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL Injection Morphine Juno JU MP NP MW C10762 C10764 C10765 5 0 5
PDP C10839 5 0 5
Injection containing morphine hydrochloride trihydrate 20 mg in 1 mL Injection Morphine Juno JU MP NP C10762 C10764 C10765 5 0 5
PDP C10839 5 0 5
Injection containing morphine hydrochloride trihydrate 50 mg in 5 mL Injection Morphine Juno JU MP NP C10762 C10764 C10765 5 0 5
Injection containing morphine hydrochloride trihydrate 100 mg in 5 mL Injection Morphine Juno JU MP NP C10762 C10764 C10765 5 0 5
Injection containing morphine sulfate pentahydrate 10 mg in 1 mL Injection DBL Morphine Sulfate Pentahydrate PF MP NP MW C10762 C10764 C10765 5 0 5
PDP C10839 5 0 5
MORPHINE SULFATE 10 mg/1 mL MEDSURGE DZ MP NP MW C10762 C10764 C10765 5 0 5
PDP C10839 5 0 5
Injection containing morphine sulfate pentahydrate 15 mg in 1 mL Injection a DBL Morphine Sulfate Pentahydrate PF MP NP MW C10762 C10764 C10765 5 0 5
PDP C10839 5 0 5
a MORPHINE SULFATE 15 mg/1 mL MEDSURGE DZ MP NP MW C10762 C10764 C10765 5 0 5
PDP C10839 5 0 5
Injection containing morphine sulfate pentahydrate 30 mg in 1 mL Injection a DBL Morphine Sulfate Pentahydrate PF MP NP C10762 C10764 C10765 5 0 5
PDP C10839 5 0 5
a MORPHINE SULFATE 30 mg/1 mL MEDSURGE DZ MP NP C10762 C10764 C10765 5 0 5
PDP C10839 5 0 5
Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 200 mL Oral Ordine 2 MF MP NP C10764 C10770 C10777 1 0 1
PDP C10859 1 0 1
Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 200 mL Oral Ordine 5 MF MP NP C10764 C10770 C10777 1 0 1
PDP C10859 1 0 1
Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 200 mL Oral Ordine 10 MF MP NP C10764 C10770 C10777 1 0 1
PDP C10859 1 0 1
Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 20 mg per sachet Oral MS Contin Suspension 20 mg MF MP NP C10748 C10752 C10755 28 0 28
Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 30 mg per sachet Oral MS Contin Suspension 30 mg MF MP NP C10748 C10752 C10755 28 0 28
Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 60 mg per sachet Oral MS Contin Suspension 60 mg MF MP NP C10748 C10752 C10755 28 0 28
Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 100 mg per sachet Oral MS Contin Suspension 100 mg MF MP NP C10748 C10752 C10755 28 0 28
Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 200 mg per sachet Oral MS Contin Suspension 200 mg MF MP NP C10756 C10814 C10836 C10858 28 0 28
Tablet containing morphine sulfate pentahydrate 5 mg (controlled release) Oral MS Contin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing morphine sulfate pentahydrate 10 mg Oral Sevredol MF MP NP C6168 C10775 C10837 C10891 P10775 P10837 P10891 20 0 20
MP NP C6168 C10775 C10837 C10891 P6168 20 2 20
Tablet containing morphine sulfate pentahydrate 10 mg (controlled release) Oral a Momex SR 10 RW MP NP C10748 C10752 C10755 28 0 28
a Morphine MR AN EA MP NP C10748 C10752 C10755 28 0 28
a MORPHINE MR APOTEX TX MP NP C10748 C10752 C10755 28 0 28
a Morphine MR Mylan AF MP NP C10748 C10752 C10755 28 0 28
a MS Contin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing morphine sulfate pentahydrate 15 mg (controlled release) Oral MS Contin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing morphine sulfate pentahydrate 20 mg Oral Sevredol MF MP NP C6168 C10775 C10837 C10891 P10775 P10837 P10891 20 0 20
MP NP C6168 C10775 C10837 C10891 P6168 20 2 20
Tablet containing morphine sulfate pentahydrate 30 mg Oral Anamorph RW MP NP C10758 C10764 C10770 C10777 P10758 10 0 20
PDP C10758 C10859 P10758 10 0 20
MP NP C10758 C10764 C10770 C10777 P10764 P10770 P10777 20 0 20
PDP C10758 C10859 P10859 20 0 20
Tablet containing morphine sulfate pentahydrate 30 mg (controlled release) Oral a Momex SR 30 RW MP NP C10748 C10752 C10755 28 0 28
a Morphine MR AN EA MP NP C10748 C10752 C10755 28 0 28
a MORPHINE MR APOTEX TX MP NP C10748 C10752 C10755 28 0 28
a Morphine MR Mylan AF MP NP C10748 C10752 C10755 28 0 28
a MS Contin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing morphine sulfate pentahydrate 60 mg (controlled release) Oral a Momex SR 60 RW MP NP C10748 C10752 C10755 28 0 28
a Morphine MR AN EA MP NP C10748 C10752 C10755 28 0 28
a MORPHINE MR APOTEX TX MP NP C10748 C10752 C10755 28 0 28
a Morphine MR Mylan AF MP NP C10748 C10752 C10755 28 0 28
a MS Contin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing morphine sulfate pentahydrate 100 mg (controlled release) Oral a Momex SR 100 RW MP NP C10748 C10752 C10755 28 0 28
a Morphine MR AN EA MP NP C10748 C10752 C10755 28 0 28
a MORPHINE MR APOTEX TX MP NP C10748 C10752 C10755 28 0 28
a Morphine MR Mylan AF MP NP C10748 C10752 C10755 28 0 28
a MS Contin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing morphine sulfate pentahydrate 200 mg (controlled release) Oral MS Contin MF MP NP C6151 C10756 C10814 C10836 C10858 P10756 P10814 P10836 P10858 28 0 28
MP NP C6151 C10756 C10814 C10836 C10858 P6151 28 2 28

  1. Schedule 1, entry for Naloxone in the form Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule

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

a NALOXONE SXP XC MP NP PDP 5 0 5

  1. Schedule 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a)omit from the column headed “Circumstances”: C8571

(b)omit from the column headed “Circumstances”: C9253

  1. Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

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

a Olmekar HCT 20/5/12.5 RF MP NP C4311 30 5 30

  1. Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

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

a Olmekar HCT 40/5/12.5 RF MP NP C4311 30 5 30

  1. Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg

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

a Olmekar HCT 40/5/25 RF MP NP C4311 30 5 30

  1. Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg

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

a Olmekar HCT 40/10/12.5 RF MP NP C4311 30 5 30

  1. Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

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

a Olmekar HCT 40/10/25 RF MP NP C4311 30 5 30

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

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

Zotren ODT RF MP NP C5618 C10498 P5618 4 0 4
MP C5743 4 0 4 C(100)

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

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

Zotren ODT RF MP NP C5618 C10498 P10498 10 1 10

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

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

Zotren ODT RF MP NP C5618 C10498 P5618 4 0 4
MP C5743 4 0 4 C(100)

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

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

Zotren ODT RF MP NP C5618 C10498 P10498 10 1 10

  1. Schedule 1, entry for Oxycodone

substitute:

Oxycodone Capsule containing oxycodone hydrochloride 5 mg Oral a Oxycodone BNM LI MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a OxyNorm MF MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Oxycodone BNM LI MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a OxyNorm MF MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
Capsule containing oxycodone hydrochloride 10 mg Oral a Oxycodone BNM LI MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a OxyNorm MF MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Oxycodone BNM LI MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a OxyNorm MF MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
Capsule containing oxycodone hydrochloride 20 mg Oral a Oxycodone BNM LI MP NP C10764 C10771 C10772 20 0 20
a OxyNorm MF MP NP C10764 C10771 C10772 20 0 20
Oral solution containing oxycodone hydrochloride 1 mg per mL, 250 mL Oral OxyNorm Liquid 1mg/mL MF MP NP C10764 C10771 C10772 1 0 1
PDP C10768 1 0 1
Suppository 30 mg (as pectinate) Rectal Proladone FF MP NP C10764 C10890 C10910 12 0 12
PDP C10860 12 0 12
Tablet containing oxycodone hydrochloride 5 mg Oral a Endone AF MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Mayne Pharma Oxycodone IR YN MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Oxycodone Aspen AL MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Endone AF MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Mayne Pharma Oxycodone IR YN MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Oxycodone Aspen AL MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
Tablet containing oxycodone hydrochloride 10 mg (controlled release) Oral a Novacodone HX MP NP C10748 C10752 C10755 28 0 28
a Oxycodone Sandoz SZ MP NP C10748 C10752 C10755 28 0 28
a OxyContin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing oxycodone hydrochloride 15 mg (controlled release) Oral OxyContin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing oxycodone hydrochloride 20 mg (controlled release) Oral a Novacodone HX MP NP C10748 C10752 C10755 28 0 28
a Oxycodone Sandoz SZ MP NP C10748 C10752 C10755 28 0 28
a OxyContin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing oxycodone hydrochloride 30 mg (controlled release) Oral OxyContin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing oxycodone hydrochloride 40 mg (controlled release) Oral a Novacodone HX MP NP C10748 C10752 C10755 28 0 28
a Oxycodone Sandoz SZ MP NP C10748 C10752 C10755 28 0 28
a OxyContin MF MP NP C10748 C10752 C10755 28 0 28
Tablet containing oxycodone hydrochloride 80 mg (controlled release) Oral a Novacodone HX MP NP C10748 C10752 C10755 28 0 28
a Oxycodone Sandoz SZ MP NP C10748 C10752 C10755 28 0 28
a OxyContin MF MP NP C10748 C10752 C10755 28 0 28

  1. Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg; and Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg

omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

  1. Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg; and Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg

omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

  1. Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg; and Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg

omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

  1. Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg; and Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg

omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

  1. Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg

omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

  1. Schedule 1, entry for Palbociclib in each of the forms: Capsule 75 mg; Capsule 100 mg; and Capsule 125 mg

(a)omit from the column headed “Circumstances”: C10013

(b)omit from the column headed “Circumstances”: C10043

(c)insert in numerical order in the column headed “Circumstances”: C10735

  1. Schedule 1, entry for Pembrolizumab

(a)omit from the column headed “Circumstances”: C9897

(b)omit from the column headed “Circumstances”: C9966

(c)omit from the column headed “Circumstances”: C10675

(d)omit from the column headed “Circumstances”: C10685

(e)insert in numerical order in the column headed “Circumstances”: C10809 C10888

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

(a)omit from the column headed “Responsible Person”: TS                  substitute: TK

(b)omit from the column headed “Circumstances”: C9466

(c)omit from the column headed “Purposes”: P9466

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

omit from the column headed “Circumstances”: C9466

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

(a)omit from the column headed “Responsible Person”: TS                  substitute: TK

(b)omit from the column headed “Circumstances”: C9466

(c)omit from the column headed “Purposes”: P9466

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

omit from the column headed “Circumstances”: C9466

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg

(a)        omit:

a Pravastatin generichealth GQ MP NP 30 5 30

(b)       omit:

a Pravastatin generichealth GQ MP P7598 30 11 30

  1. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562 C8012 C8017 C8026 C8027 C8029 substitute: C10708 C10710 C10714 C10780 C10785 C10786 C10787 C10818 C10819 C10881 C10882 C10893

(b)omit from the column headed “Purposes”: P7515 P7551 P7552 P7560 P7561 P7562 P8012 P8017 P8026 P8027 P8029   substitute: P10708 P10710 P10714 P10780 P10786 P10787 P10818 P10819 P10881 P10893

  1. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562 C8012 C8017 C8026 C8027 C8029 substitute: C10708 C10710 C10714 C10780 C10785 C10786 C10787 C10818 C10819 C10881 C10882 C10893

(b)omit from the column headed “Purposes”: P7511 P7514                 substitute: P10785 P10882

  1. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562 C8012 C8017 C8026 C8027 C8029 substitute: C10708 C10710 C10714 C10780 C10785 C10786 C10787 C10818 C10819 C10881 C10882 C10893

(b)omit from the column headed “Purposes”: P7515 P7551 P7552 P7560 P7561 P7562 P8012 P8017 P8026 P8027 P8029   substitute: P10708 P10710 P10714 P10780 P10786 P10787 P10818 P10819 P10881 P10893

  1. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562 C8012 C8017 C8026 C8027 C8029 substitute: C10708 C10710 C10714 C10780 C10785 C10786 C10787 C10818 C10819 C10881 C10882 C10893

(b)omit from the column headed “Purposes”: P7511 P7514                 substitute: P10785 P10882

  1. Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

omit:

a Ranitidine GH GQ MP NP MW 60 5 60

  1. Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)

omit:

a Ranitidine GH GQ MP NP 30 5 30

  1. Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances” (all instances): C10052

(b)omit from the column headed “Purposes” (all instances): P10052

  1. Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 5]

omit from the column headed “Circumstances” (all instances): C10052

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances” (all instances): C10052

(b)omit from the column headed “Purposes” (all instances): P10052

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]

omit from the column headed “Circumstances” (all instances): C10052

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances” (all instances): C10052

(b)omit from the column headed “Purposes” (all instances): P10052

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]

omit from the column headed “Circumstances” (all instances): C10052

  1. Schedule 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)

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

Rizatriptan-AU DZ MP NP C5708 4 5 2

  1. Schedule 1, entry for Tadalafil

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

Tadalca CR MP See Note 3 See Note 3 See Note 3 See Note 3 56 D(100)

  1. Schedule 1, entry for Tapentadol in each of the forms: Tablet (modified release) 50 mg (as hydrochloride); and Tablet (modified release) 100 mg (as hydrochloride)

omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

  1. Schedule 1, entry for Tapentadol in each of the forms: Tablet (modified release) 150 mg (as hydrochloride); and Tablet (modified release) 200 mg (as hydrochloride)

omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

  1. Schedule 1, entry for Tapentadol in the form Tablet (modified release) 250 mg (as hydrochloride)

omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

  1. Schedule 1, entry for Tenofovir with emtricitabine and efavirenz

omit:

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg Oral Atripla GI MP NP C4470 C4522 60 5 30 D(100)

  1. Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]

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

a NOUMED TERBINAFINE VO MP NP C6395 C6404 C6453 P6404 P6453 42 0 42

  1. Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 1]

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

a NOUMED TERBINAFINE VO MP NP C6395 C6404 C6453 P6395 42 1 42

  1. Schedule 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C8475 C8872 C8908 C8933 C8953 C8970 C8972 C8994 C8995 C8996 C9947 C9997 substitute: C10802 C10806 C10807 C10832 C10833 C10852 C10853 C10854 C10873 C10889

(b)omit from the column headed “Purposes”: P8475 P8933 P8953 P8970 P8994              substitute: P10806 P10807 P10889

  1. Schedule 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8475 C8872 C8908 C8933 C8953 C8970 C8972 C8994 C8995 C8996 C9947 C9997 substitute: C10802 C10806 C10807 C10832 C10833 C10852 C10853 C10854 C10873 C10889

(b)omit from the column headed “Purposes”: P8872 P8908 P8972 P8995 P8996 P9947 P9997   substitute: P10802 P10832 P10833 P10852 P10853 P10854 P10873

  1. Schedule 1, entry for Tramadol

substitute:

Tramadol Capsule containing tramadol hydrochloride 50 mg Oral a APO-Tramadol TX MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Tramadol AMNEAL EF MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Tramadol AN EA MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Tramadol Sandoz SZ MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Tramadol SCP CR MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Tramal CS MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Tramedo AF MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a Zydol RW MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
a APO-Tramadol TX MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Tramadol AMNEAL EF MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Tramadol AN EA MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Tramadol Sandoz SZ MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Tramadol SCP CR MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Tramal CS MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Tramedo AF MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
a Zydol RW MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
Injection containing tramadol hydrochloride 100 mg in 2 mL Injection a Tramadol ACT JO MP NP C10764 C10771 C10772 5 0 5
PDP C10768 5 0 5
a Tramadol AN JU MP NP C10764 C10771 C10772 5 0 5
PDP C10768 5 0 5
a Tramadol Sandoz SZ MP NP C10764 C10771 C10772 5 0 5
PDP C10768 5 0 5
a Tramal 100 CS MP NP C10764 C10771 C10772 5 0 5
PDP C10768 5 0 5
Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL Oral Tramal CS MP NP C10764 C10771 C10772 1 0 1
PDP C10768 1 0 1
Tablet (sustained release) containing tramadol hydrochloride 50 mg Oral Tramal SR 50 CS MP NP C10748 C10752 C10755 20 0 20
Tablet (sustained release) containing tramadol hydrochloride 100 mg Oral a APO-Tramadol SR TX MP NP C10748 C10752 C10755 20 0 20
a Tramadol AN SR EA MP NP C10748 C10752 C10755 20 0 20
a Tramadol Sandoz SR SZ MP NP C10748 C10752 C10755 20 0 20
a Tramadol SR generichealth GQ MP NP C10748 C10752 C10755 20 0 20
a Tramal SR 100 CS MP NP C10748 C10752 C10755 20 0 20
a Tramedo SR AL MP NP C10748 C10752 C10755 20 0 20
a Zydol SR 100 RW MP NP C10748 C10752 C10755 20 0 20
Tablet (sustained release) containing tramadol hydrochloride 150 mg Oral a APO-Tramadol SR TX MP NP C10748 C10752 C10755 20 0 20
a Tramadol AN SR EA MP NP C10748 C10752 C10755 20 0 20
a Tramadol Sandoz SR SZ MP NP C10748 C10752 C10755 20 0 20
a Tramadol SR generichealth GQ MP NP C10748 C10752 C10755 20 0 20
a Tramal SR 150 CS MP NP C10748 C10752 C10755 20 0 20
a Tramedo SR AL MP NP C10748 C10752 C10755 20 0 20
a Zydol SR 150 RW MP NP C10748 C10752 C10755 20 0 20
Tablet (sustained release) containing tramadol hydrochloride 200 mg Oral a APO-Tramadol SR TX MP NP C10748 C10752 C10755 20 0 20
a Tramadol AN SR EA MP NP C10748 C10752 C10755 20 0 20
a Tramadol Sandoz SR SZ MP NP C10748 C10752 C10755 20 0 20
a Tramadol SR generichealth GQ MP NP C10748 C10752 C10755 20 0 20
a Tramal SR 200 CS MP NP C10748 C10752 C10755 20 0 20
a Tramedo SR AL MP NP C10748 C10752 C10755 20 0 20
a Zydol SR 200 RW MP NP C10748 C10752 C10755 20 0 20

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

omit from the column headed “Circumstances”: C8579

  1. Schedule 4, Part 1, entry for Adalimumab

(a)        omit:

C6951 Moderate to severe hidradenitis suppurativa
Initial treatment 1 - New patient
Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND
Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR
Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR
Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND
The treatment must be limited to a maximum duration of 16 weeks.
Must be treated by a dermatologist.
Assessment of disease severity must be no more than 1 month old at the time of application.
An assessment of the patient's response to this recommencement course of treatment must be made following a minimum of 12 weeks of treatment.
At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment - balance of supply
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include:
(i) the Hurley stage grading; and
(ii) the AN count; and
(iii) the name of the antibiotic/s received for two separate courses each of three months; or
(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics
(v) a signed patient acknowledgement. 		Compliance with Authority Required procedures

(b)       omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C6963”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

(c)        omit:

C6971 P6971 Moderate to severe hidradenitis suppurativa
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated a response to treatment with this drug for this condition.
Must be treated by a dermatologist.
A response to treatment is defined as:
Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and provided to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include the Hidradenitis Suppurativa Clinical Response (HiSCR) result. 		Compliance with Authority Required procedures
C6972 P6972 Moderate to severe hidradenitis suppurativa
Initial treatment 3 - Grandfathered patient
Patient must have been receiving treatment with this drug for this condition prior to 1 July 2017; AND
Patient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug; AND
Patient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 12 weeks of treatment if the patient has been treated with this drug for this condition for 12 weeks or longer; AND
Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR
Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR
Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition.
Must be treated by a dermatologist.
A response to treatment is defined as:
Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and provided to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
Assessment of disease severity must be no more than 1 month old at the time treatment with this drug was initiated.
A maximum of 24 weeks treatment will be authorised under this restriction.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria or recommencement of treatment criteria where there is a break in treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) completed hidradenitis suppurativa PBS authority application supporting Information form which must include:
(i) the Hurley stage grading; and
(ii) the AN count; and
(iii) the name of the antibiotic/s received for two separate courses each of three months; or
(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics
(v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 12 weeks or more of treatment
(vi) a signed patient acknowledgement. 		Compliance with Authority Required procedures

(d)       insert in numerical order after existing text:

C10838 P10838 Moderate to severe hidradenitis suppurativa
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated a response to treatment with this drug for this condition.
Must be treated by a dermatologist.
A response to treatment is defined as:
Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and must be provided no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include the Hidradenitis Suppurativa Clinical Response (HiSCR) result. 		Compliance with Written Authority Required procedures
C10892 Moderate to severe hidradenitis suppurativa
Initial treatment 1 - New patient
Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND
Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR
Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR
Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND
The treatment must be limited to a maximum duration of 16 weeks.
Must be treated by a dermatologist.
Assessment of disease severity must be no more than 1 month old at the time of application.
An assessment of the patient's response to this recommencement course of treatment must be made following a minimum of 12 weeks of treatment.
At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment - balance of supply
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include:
(i) the Hurley stage grading; and
(ii) the AN count; and
(iii) the name of the antibiotic/s received for two separate courses each of three months; or
(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Aflibercept

substitute:

Aflibercept C10708 P10708 Subfoveal choroidal neovascularisation (CNV)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to pathologic myopia (PM); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; 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 Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report. 		Compliance with Written Authority Required procedures
C10715 P10715 Subfoveal choroidal neovascularisation (CNV)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; 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 Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report. 		Compliance with Written Authority Required procedures
C10716 P10716 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
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
C10783 P10783 Central retinal vein occlusion with macular oedema
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 macular oedema secondary to central retinal vein occlusion (CRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), 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
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 Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report. 		Compliance with Written Authority Required procedures
C10789 P10789 Branch retinal vein occlusion with macular oedema
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures
C10818 P10818 Subfoveal choroidal neovascularisation (CNV)
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to pathologic myopia (PM); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. 		Compliance with Authority Required procedures
C10826 P10826 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 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
C10827 P10827 Central retinal vein occlusion with macular oedema
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures
C10862 P10862 Subfoveal choroidal neovascularisation (CNV)
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye. 		Compliance with Authority Required procedures
C10911 P10911 Branch retinal vein occlusion with macular oedema
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 macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), 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
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 Retinal Vein Occlusion Initial PBS authority application 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 Alectinib

omit:

C7353 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 January 2018; AND
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not have progressive disease while receiving treatment with this drug for this condition.
Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Apomorphine

(a)        omit:

C6813 Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy. 		Compliance with Authority Required procedures - Streamlined Authority Code 6813

(b)       insert in numerical order after existing text:

C10830 Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
The treatment must be commenced in a specialist unit in a hospital setting. 		Compliance with Authority Required procedures - Streamlined Authority Code 10830
C10844 Parkinson disease
Maintenance therapy
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
Patient must have been commenced on treatment in a specialist unit in a hospital setting. 		Compliance with Authority Required procedures - Streamlined Authority Code 10844
C10863 Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
The treatment must be commenced in a specialist unit in a hospital setting. 		Compliance with Authority Required procedures - Streamlined Authority Code 10863

  1. Schedule 4, Part 1, entry for Brentuximab vedotin

(a)        omit:

C6903 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and
(c) a signed patient acknowledgement. 		Compliance with Authority Required procedures
C6936 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT); AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and
(c) a signed patient acknowledgement. 		Compliance with Authority Required procedures

(b)       insert in numerical order after existing text:

C10811 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT); AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application. 		Compliance with Written Authority Required procedures
C10902 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Buprenorphine

(a)        omit:

C10445 P10445 Chronic severe pain
The condition must require daily, continuous, long term therapy with this treatment; AND
Patient must have pain directly attributable to cancer; OR
Patient must have previously experienced inadequate management of pain relief following maximum tolerated doses of non-opioid or other opioid analgesics; OR
The condition must be such that maximum tolerated doses of non-opioid or other opioid analgesics would provide inadequate management of pain relief; OR
Patient must be unable to use non-opioid or other opioid analgesics due to contraindications, adverse effects or intolerance.
Authorities for increased maximum quantities and/or repeats must only be considered for:
(i) chronic severe disabling pain where the total duration of non-PBS and PBS-subsidised opioid analgesic treatment is less than 12 months; or
(ii) chronic severe disabling pain where the total duration of non-PBS and PBS-subsidised opioid analgesic treatment will or has exceeded 12 months and the patient's pain management has been reviewed through consultation with the patient by another medical practitioner, and the clinical need for continuing opioid analgesic treatment has been confirmed immediately prior to the first application or at least once in the past 12 months for subsequent applications. The full name of the medical practitioner consulted and the date of the most recent consultation are to be provided at the time of each application; or
(iii) chronic severe disabling pain where the total duration of non-PBS and PBS-subsidised opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's pain management has not been reviewed through consultation with the patient by another medical practitioner to confirm the clinical need for continuing opioid analgesic treatment. A review must have been planned to take place within 3 months from the date of this application. The full name of the medical practitioner consulted and the date of the consultation are to be provided at the time of the application.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and up to 2 repeats). 		Compliance with Authority Required procedures - Streamlined Authority Code 10445

  1. Schedule 4, Part 1, entry for Risperidone

omit:

C10052 P10052 Behavioural disturbances
Grandfather treatment for the trial of dose reduction or cessation of treatment in a patient prescribed risperidone prior to 1 January 2020
The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia of the Alzheimer type; AND
Patient must have received PBS-subsidised treatment with this drug for this condition prior to 1 January 2020; AND
Patient must have responded to PBS-subsidised treatment with this drug for this condition; AND
Patient must have failed to respond to non-pharmacological methods of treatment; AND
Patient must be optimised on non-pharmacological methods of treatment; AND
The treatment must be for dose tapering purposes as part of a trial of treatment reduction or cessation; OR
Patient must have trialled a period of treatment reduction or cessation with this drug for this condition and experienced worsening or re-emergence of symptoms during this trial, and retrials are considered periodically; AND
Patient must not receive more than 12 weeks of treatment under this restriction.
A patient may only qualify for PBS-subsidised treatment under this restriction once in a lifetime.
The patient's response to treatment and a trial of treatment reduction or cessation must be discussed formally with a psychiatrist or geriatrician or in a documented clinical review process involving a least one other medical practitioner, or be reviewed by a psychiatrist or geriatrician.
Response to treatment is defined as a significant reduction in symptoms of psychosis or aggression.
Patients must cease treatment if there is no improvement in symptoms of psychosis and aggression, or worsening of symptoms with therapy.
Patients must be monitored for adverse effects such as falls, drowsiness leading to reduced self-care, incontinence, reduced nutrition, reduced ability to communicate needs/wishes and take part in activities. Therapy must be ceased if harms of therapy outweigh benefits.
Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy. 		Compliance with Authority Required procedures - Streamlined Authority Code 10052

  1. Schedule 4, Part 1, entry for Tapentadol

substitute:

Tapentadol C10748 Chronic severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months
The condition must require daily, continuous, long term opioid treatment; AND
Patient must have cancer pain; OR
Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; OR
Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:
(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or
(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). 		Compliance with Authority Required procedures - Streamlined Authority Code 10748
C10752 Chronic severe pain
Continuing PBS treatment after 1 June 2020
Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.
Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:
(i) is less than 12 months; or
(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or
(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). 		Compliance with Authority Required procedures - Streamlined Authority Code 10752
C10755 Chronic severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months
The condition must require daily, continuous, long term opioid treatment; AND
Patient must have cancer pain; OR
Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; OR
Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). 		Compliance with Authority Required procedures - Streamlined Authority Code 10755

  1. Schedule 4, Part 1, entry for Tildrakizumab

substitute:

Tildrakizumab C10802 P10802 Severe chronic plaque psoriasis
Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C10806 P10806 Severe chronic plaque psoriasis
Continuing treatment, Whole body
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Written Authority Required procedures
C10807 P10807 Severe chronic plaque psoriasis
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply
Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
Must be treated by a dermatologist. 		Compliance with Authority Required procedures
C10832 P10832 Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. 		Compliance with Written Authority Required procedures
C10833 P10833 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, cyclosporin, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. 		Compliance with Written Authority Required procedures
C10852 P10852 Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. 		Compliance with Written Authority Required procedures
C10853 P10853 Severe chronic plaque psoriasis
Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C10854 P10854 Severe chronic plaque psoriasis
Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.
Must be treated by a dermatologist. 		Compliance with Authority Required procedures
C10873 P10873 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, cyclosporin, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. 		Compliance with Written Authority Required procedures
C10889 P10889 Severe chronic plaque psoriasis
Continuing treatment, Face, hand, foot
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Tramadol

substitute:

Tramadol C10748 Chronic severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months
The condition must require daily, continuous, long term opioid treatment; AND
Patient must have cancer pain; OR
Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; OR
Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:
(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or
(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). 		Compliance with Authority Required procedures - Streamlined Authority Code 10748
C10752 Chronic severe pain
Continuing PBS treatment after 1 June 2020
Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.
Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:
(i) is less than 12 months; or
(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or
(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). 		Compliance with Authority Required procedures - Streamlined Authority Code 10752
C10755 Chronic severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months
The condition must require daily, continuous, long term opioid treatment; AND
Patient must have cancer pain; OR
Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; OR
Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). 		Compliance with Authority Required procedures - Streamlined Authority Code 10755
C10764 P10764 Severe pain
Continuing PBS treatment after 1 June 2020
Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.
Authorities for increased maximum quantities and/or repeats must only be considered where the patient has received initial authority approval for:
(i) severe disabling pain associated with malignant neoplasia; or
(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months; or
(iii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or
(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(v) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
C10766 P10766 Severe pain
The treatment must be for short term therapy of acute severe pain; AND
Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; OR
Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.
C10768 P10768 Severe pain
Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; OR
Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.
C10771 P10771 Severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months
Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; OR
Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
C10772 P10772 Severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months
Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; OR
Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats must only be considered for:
(i) severe disabling pain associated with proven malignant neoplasia; or
(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or
(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).

  1. Schedule 4, Part 1, entry for Venetoclax

omit:

C8579 Chronic lymphocytic leukaemia (CLL)
Grandfathered treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 March 2019; AND
Patient must have been considered unsuitable for treatment or retreatment with a purine analogue prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND
The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment with this drug for this condition, whichever comes first.
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

  1. Schedule 5, after entry for Abacavir with lamivudine [GRP-21981]

insert:

Aflibercept GRP-24277 Solution for intravitreal injection 3.6 mg in 90 microlitres
(40 mg per mL) pre-filled syringe 		Injection Eylea
Solution for intravitreal injection 4 mg in 100 microlitres
(40 mg per mL) 		Injection Eylea

  1. Schedule 5, after entry for Aflibercept [GRP-24277] 

insert:

Amino acid formula with vitamins and minerals without phenylalanine GRP-24285 Sachets containing oral powder 27.8 g, 30 (PKU Lophlex) Oral PKU Lophlex
Sachets containing oral powder 28 g, 30 (PKU Lophlex) Oral PKU Lophlex

  1. Schedule 5, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL [GRP-20890]

omit from the column headed “Brand”: DBL Morphine Pentahydrate                 substitute: DBL Morphine Sulphate Pentahydrate

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

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

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

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

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

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

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

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

  1. Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate) [GRP-17623]

insert in alphabetical order in the column headed “Brand”: Rizatriptan-AU

  1. Schedule 5, omit entry for Tenofovir with emtricitabine and efavirenz

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