National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 2) (PB 10 of 2019) (Cth)

Case

PB 10 of 2019

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 2)

National Health Act 1953

___________________________________________________________________________

I, THEA DANIEL, 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    26 February 2019

THEA DANIEL

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 2019 (No. 2).

(2)This Instrument may also be cited as PB 10 of 2019.

  1. Commencement

This Instrument commences on 1 March 2019.

  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 Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

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

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

(c)omit from the column headed "Purposes": P3695 P3747

(d)insert in numerical order in the column headed “Purposes”: P8547 P8587 P8594

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

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

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

(c)omit from the column headed "Purposes": P3697 P3748

(d)insert in numerical order in the column headed “Purposes”: P8567 P8608

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe, 6 [Maximum Quantity: 1; Number of Repeats: 0]

(a)omit from the column headed "Circumstances": C3695 C3747

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8587 C8594

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

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

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

(c)omit from the column headed "Purposes": P3695 P3747

(d)insert in numerical order in the column headed “Purposes”: P8547 P8587 P8594

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

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

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C3695 C3697 C3747 C3748

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8567 C8587 C8594 C8608

(c)omit from the column headed "Purposes": P3697 P3748

(d)insert in numerical order in the column headed “Purposes”: P8567 P8608

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6 [Maximum Quantity: 1; Number of Repeats: 0]

(a)omit from the column headed "Circumstances": C3695 C3747

(b)insert in numerical order in the column headed “Circumstances”: C8547 C8587 C8594

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

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

a Amisulpride Sandoz Pharma HX MP NP C4246 30 5 30

  1. Schedule 1, entry for Amisulpride in the form Tablet 400 mg

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

a Amisulpride Sandoz Pharma HX MP NP C4246 60 5 60

  1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium)

(a)omit:

a APO-Amlodipine/Atorvastatin 5/10 TX MP NP 30 5 30

(b)omit from the column headed “Schedule Equivalent” for the brand “Cadivast 5/10”: a

  1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) 

(a)omit:

a APO-Amlodipine/Atorvastatin 5/20 TX MP NP 30 5 30

(b)omit from the column headed “Schedule Equivalent” for the brand “Cadivast 5/20”: a

  1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

omit:

a APO-Amlodipine/Atorvastatin 5/40 TX MP NP 30 5 30

  1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) 

omit:

a APO-Amlodipine/Atorvastatin 5/80 TX MP NP 30 5 30

  1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) 

omit:

a APO-Amlodipine/Atorvastatin 10/10 TX MP NP 30 5 30

  1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium)

omit:

a APO-Amlodipine/Atorvastatin 10/20 TX MP NP 30 5 30

  1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

omit:

a APO-Amlodipine/Atorvastatin 10/40 TX MP NP 30 5 30

  1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

omit:

a APO-Amlodipine/Atorvastatin 10/80 TX MP NP 30 5 30

  1. Schedule 1, entry for Axitinib in the form Tablet 1 mg [Maximum Quantity: 56; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C5733

(b)insert in numerical order in the column headed "Circumstances": C8588

(c)omit from the column headed "Purposes": P5733        substitute: P8588

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

(a)omit from the column headed "Circumstances": C5733

(b)insert in numerical order in the column headed "Circumstances": C8588

  1. Schedule 1, entry for Axitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C5733

(b)insert in numerical order in the column headed "Circumstances": C8588

(c)omit from the column headed "Purposes": P5733        substitute: P8588

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

(a)omit from the column headed "Circumstances": C5733

(b)insert in numerical order in the column headed "Circumstances": C8588

  1. Schedule 1, entry for Betaine in the form Oral powder 180 g

omit from the column headed "Responsible Person": EU         substitute: RJ

  1. Schedule 1, after entry for Bicalutamide in the form Tablet 50 mg

insert:

Bictegravir with emtricitabine with tenofovir alafenamide Tablet containing bictegravir 50 mg with emtricitabine 200 mg with tenofovir alafenamide 25 mg Oral Biktarvy GI MP C4470 C4522 60 5 30 D(100)

  1. Schedule 1, entry for Cabozantinib in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C7639

(b)insert in numerical order in the column headed "Circumstances": C8572

(c)omit from the column headed "Purposes": P7639        substitute: P8572

  1. Schedule 1, entry for Cabozantinib in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C7639

(b)insert in numerical order in the column headed "Circumstances": C8572

  1. Schedule 1, entry for Cabozantinib in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C7639

(b)insert in numerical order in the column headed "Circumstances": C8572

(c)omit from the column headed "Purposes": P7639        substitute: P8572

  1. Schedule 1, entry for Cabozantinib in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C7639

(b)insert in numerical order in the column headed "Circumstances": C8572

  1. Schedule 1, entry for Cabozantinib in the form Tablet 60 mg [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C7639

(b)insert in numerical order in the column headed "Circumstances": C8572

(c)omit from the column headed "Purposes": P7639        substitute: P8572

  1. Schedule 1, entry for Cabozantinib in the form Tablet 60 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C7639

(b)insert in numerical order in the column headed "Circumstances": C8572

  1. Schedule 1, entry for Carboplatin

omit:

Solution for I.V. injection 50 mg in 5 mL Injection Hospira Pty Limited PF MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

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

a Duloxetine Sandoz HX MP NP C5650 28 0 28

  1. Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

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

a Duloxetine Sandoz HX MP NP C5650 28 5 28

  1. Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

 omit:

a Escitalopram generichealth GQ MP NP C4755 28 5 28

  1. Schedule 1, entry for Everolimus in the form dispersible tablet 2 mg

omit from the column headed "Form": dispersible tablet 2 mg        substitute: Tablet, dispersible, 2 mg

  1. Schedule 1, entry for Everolimus in the form dispersible tablet 3 mg

omit from the column headed "Form": dispersible tablet 3 mg        substitute: Tablet, dispersible, 3 mg

  1. Schedule 1, entry for Everolimus in the form dispersible tablet 5 mg

omit from the column headed "Form": dispersible tablet 5 mg         substitute: Tablet, dispersible, 5mg

  1. Schedule 1, entry for Everolimus in the form Tablet 5 mg [Brand: Afinitor; Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4604       

(b)insert in numerical order in the column headed "Circumstances": C8622

(c)omit from the column headed "Purposes": P4604

(d)insert in numerical order in the column headed "Purposes": P8622

  1. Schedule 1, entry for Everolimus in the form Tablet 5 mg [Brand: Afinitor; Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4604

(b)insert in numerical order in the column headed "Circumstances": C8622

  1. Schedule 1, entry for Everolimus in the form Tablet 10 mg [Brand: Afinitor; Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4604

(b)insert in numerical order in the column headed "Circumstances": C8622

(c)omit from the column headed "Purposes": P4604

(d)insert in numerical order in the column headed "Purposes": P8622

  1. Schedule 1, entry for Everolimus in the form Tablet 10 mg [Brand: Afinitor; Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4604

(b)insert in numerical order in the column headed "Circumstances": C8622

  1. Schedule 1, entry for Ferric carboxymaltose

omit from the column headed “Brand”:  ferinject       substitute: Ferinject

  1. Schedule 1, entry for Fluticasone in the form Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)

 omit:

a FLUAIR Inhaler YC MP NP 1 5 1

  1. Schedule 1, entry for Fluticasone in the form Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation)

 omit:

a FLUAIR Inhaler YC MP NP 1 1 1

  1. Schedule 1, entry for Glycomacropeptide and essential amino acids with vitamins and minerals

insert in the columns in the order indicated, and in alphabetical order for the column headed "Form":

Oral liquid 250 mL, 30 (PKU Glytactin RTD 15 Lite) Oral PKU Glytactin RTD 15 Lite QH MP NP C5012 4 5 1

  1. Schedule 1, entry for Guanfacine in each of the forms: Tablet 1 mg (as hydrochloride); Tablet 2 mg (as hydrochloride); Tablet 3 mg (as hydrochloride); and Tablet 4 mg (as hydrochloride)

omit from the column headed "Circumstances": C7874 C7889        substitute: C8544 C8564 C8585

  1. Schedule 1, entry for Hypromellose

insert as first entry:

Hypromellose Eye drops 3 mg per mL, 10 mL Application to the eye a Genteal AQ AO C6120 1 5 1
MP C6073 C6098 P6073 1 5 1
NP C6073 1 5 1
a In a Wink Moisturising IQ AO C6120 1 5 1
MP C6073 C6098 P6073 1 5 1
NP C6073 1 5 1
a Genteal AQ MP C6073 C6098 P6098 1 11 1
a In a Wink Moisturising IQ MP C6073 C6098 P6098 1 11 1

  1. Schedule 1, after entry for Insulin lispro in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5

insert:

Injections (human analogue), pre-filled pen, 200 units per mL, 3 mL, 5 Injection Humalog U200 Kwikpen LY MP NP 5 1 1

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

insert in numerical order in the column headed "Circumstances": C8555 C8569

  1. Schedule 1, entry for Irbesartan in the form Tablet 75 mg

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

a Abisart 75 AL MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan in the form Tablet 150 mg

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

a Abisart 150 AL MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan in the form Tablet 300 mg

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

a Abisart 300 AL MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 150 mg-12.5 mg

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

a Abisart HCTZ 150/12.5 AL MP NP C4374 30 5 30

  1. Schedule 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-12.5 mg

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

a Abisart HCTZ 300/12.5 AL MP NP C4374 30 5 30

  1. Schedule 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-25 mg

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

a Abisart HCTZ 300/25 AL MP NP C4374 30 5 30

  1. Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a)insert in numerical order in the column headed "Circumstances": C8562 C8583 C8591 C8592 C8602 C8612

(b)insert in numerical order in the column headed "Purposes": P8562 P8583 P8591 P8592 P8602 P8612

  1. Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

insert in numerical order in the column headed "Circumstances": C8562 C8583 C8591 C8592 C8602 C8612

  1. Schedule 1, entry for Latanoprost

 omit:

a Latanoprost GH GQ AO MP 1 5 1

  1. Schedule 1, entry for Lenvatinib

substitute:

Lenvatinib Capsule 4 mg (as mesilate) Oral Lenvima EI MP C6578 C6604 C8584 C8593 C8618 P6578 P6604 30 2 30
MP C6578 C6604 C8584 C8593 C8618 P8584 P8593 P8618 90 2 30
Capsule 10 mg (as mesilate) Oral Lenvima EI MP C6578 C6604 60 2 30

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

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

a Metformin GH HQ MP NP 90 5 90

  1. Schedule 1, entry for Methoxyflurane in the form Liquid for inhalation 999.9 mg per g, 3 mL (with inhaler)

omit from the column headed "Form": 999.9 substitute: 999

  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": C6988 C6993

(b)insert in numerical order in the column headed "Circumstances": C8552 C8568 C8571 C8573 C8581

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 0]

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

a Mendeleev Paracetamol HX PDP C5846 C5885 P5846 100 0 100

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 1]

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

a Mendeleev Paracetamol HX MP NP C5835 C5865 P5835 100 1 100

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 0]

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

a Mendeleev Paracetamol HX PDP C5846 C5885 P5885 300 0 100

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 4]

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

a Mendeleev Paracetamol HX MP NP C5835 C5865 P5865 300 4 100

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 4]

omit from the entry for the brand "PHARMACY CARE PARACETAMOL":

MP P4072 2 11 1

  1. Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4148

(b)insert in numerical order in the column headed "Circumstances": C8551

  1. Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4148

(b)insert in numerical order in the column headed "Circumstances": C8551

(c)omit from the column headed "Purposes": P4148

(d)insert in numerical order in the column headed "Purposes": P8551

  1. Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4148

(b)insert in numerical order in the column headed "Circumstances": C8551

  1. Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4148

(b)insert in numerical order in the column headed "Circumstances": C8551

  1. Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4148

(b)insert in numerical order in the column headed "Circumstances": C8551

(c)omit from the column headed "Purposes": P4148

(d)insert in numerical order in the column headed "Purposes": P8551

  1. Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4148

(b)insert in numerical order in the column headed "Circumstances": C8551

  1. Schedule 1, entry for Pembrolizumab in the form Solution concentrate for I.V. infusion 100 mg in 4 mL

insert in numerical order in the column headed "Circumstances": C8542 C8543 C8563

  1. Schedule 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 21; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C7731 C7739 C7752

(b)insert in numerical order in the column headed "Circumstances": C8556 C8557 C8599

(c)omit from the column headed "Purposes": P7731

(d)insert in numerical order in the column headed "Purposes": P8556

  1. Schedule 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 42; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C7731 C7739 C7752

(b)insert in numerical order in the column headed "Circumstances": C8556 C8557 C8599

(c)omit from the column headed "Purposes": P7739

(d)insert in numerical order in the column headed "Purposes": P8557

  1. Schedule 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 63; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C7731 C7739 C7752

(b)insert in numerical order in the column headed "Circumstances": C8556 C8557 C8599

(c)omit from the column headed "Purposes": P7752

(d)insert in numerical order in the column headed "Purposes": P8599

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

insert in numerical order in the column headed "Circumstances": C4132

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

insert in numerical order in the column headed "Circumstances": C4132

  1. Schedule 1, entry for Rivaroxaban in the form Tablet 10 mg [Maximum Quantity: 15; Number of Repeats: 0]

insert in numerical order in the column headed "Circumstances": C4132

  1. Schedule 1, entry for Rivaroxaban in the form Tablet 10 mg [Maximum Quantity: 15; Number of Repeats: 1]

insert in numerical order in the column headed "Circumstances": C4132

  1. Schedule 1, entry for Rivaroxaban in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 0]

insert in numerical order in the column headed "Circumstances": C4132

  1. Schedule 1, after entry for Rivaroxaban in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 0]

insert in the columns in the order indicated:

MP NP C4132 C4369 C4381 C4382 C4402 P4132 30 5 30

  1. Schedule 1, entry for Roxithromycin in the form Tablet 150 mg

(a)omit:

a Roxithromycin GH GQ PDP 10 0 10

(b)omit:

a Roxithromycin GH GQ MP NP 10 1 10

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

(a)omit from the column headed "Circumstances": C4230 C4234 C4841

(b)insert in numerical order in the column headed "Circumstances": C8616 C8617 C8621

(c)omit from the column headed "Purposes": P4230 P4234 P4841 substitute: P8616 P8617 P8621

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

(a)omit from the column headed "Circumstances": C4230 C4234 C4841

(b)insert in numerical order in the column headed "Circumstances": C8616 C8617 C8621

  1. Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

(c)omit from the column headed "Purposes": P4119

(d)insert in numerical order in the column headed "Purposes": P8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

(c)omit from the column headed "Purposes": P4119

(d)insert in numerical order in the column headed "Purposes": P8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

(c)omit from the column headed "Purposes": P4119

(d)insert in numerical order in the column headed "Purposes": P8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

(c)omit from the column headed "Purposes": P4119

(d)insert in numerical order in the column headed "Purposes": P8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4119

(b)insert in numerical order in the column headed "Circumstances": C8549

  1. Schedule 1, entry for Tiotropium in the form Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations)

(a)omit from the column headed "Circumstances": C6777

(b)insert in numerical order in the column headed "Circumstances": C8605 C8606

  1. Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg

 omit:

a Topiramate GH GQ MP NP C5325 C5516 60 5 60

  1. Schedule 1, entry for Topiramate in the form Tablet 200 mg

 omit:

a Topiramate GH GQ MP NP C5516 60 5 60

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 20; Number of Repeats: 0]

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

a Valaciclovir APOTEX GX MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

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

a Valaciclovir APOTEX GX MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 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 Valaciclovir APOTEX GX MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 500; Number of Repeats: 2]

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

a Valaciclovir APOTEX GX MP C5939 C5975 500 2 100 C(100)

  1. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 80 mg-12.5 mg 

(a)omit:

a APO-Valsartan HCTZ 80/12.5 TX MP NP C4374 28 5 28

(b)omit from the column headed “Schedule Equivalent” for the brand “Co-Diovan 80/12.5”: a

  1. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-12.5 mg

(a)omit:

a APO-Valsartan HCTZ 160/12.5 TX MP NP C4374 28 5 28

(b)omit from the column headed “Schedule Equivalent” for the brand “Co-Diovan 160/12.5”: a

  1. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-25 mg

(a)omit:

a APO-Valsartan HCTZ 160/25 TX MP NP C4374 28 5 28

(b)omit from the column headed “Schedule Equivalent” for the brand “Co-Diovan 160/25”: a

  1. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-12.5 mg

(a)omit:

a APO-Valsartan HCTZ 320/12.5 TX MP NP C4361 28 5 28

(b)omit from the column headed “Schedule Equivalent” for the brand “Co-Diovan 320/12.5”: a

  1. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-25 mg 

(a)omit:

a APO-Valsartan HCTZ 320/25 TX MP NP C4361 28 5 28

(b)omit from the column headed “Schedule Equivalent” for the brand “Co-Diovan 320/25”: a

  1. Schedule 1, after entry for Vemurafenib in the form Tablet 240 mg

insert:

Venetoclax Pack containing 14 tablets venetoclax 10 mg and 7 tablets venetoclax 50 mg and 7 tablets venetoclax 100 mg and 14 tablets venetoclax 100 mg Oral Venclexta VE MP C8607 1 0 1
Tablet 10 mg Oral Venclexta VE MP C8565 14 0 14
Tablet 50 mg Oral Venclexta VE MP C8565 7 0 7
Tablet 100 mg Oral Venclexta VE MP C8579 C8586 120 5 120

  1. Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

 omit:

DEZTRON DZ MP C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 1 11 1 PB(100)

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

insert:

RJ Recordati Rare Diseases Australia Pty. Ltd. 26 627 263 094

  1. Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C3695 P3695

Fistulising Crohn disease — initial treatment 1

PBS-IN-WRITING/ Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has an externally draining enterocutaneous or rectovaginal fistula; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the most recent fistula assessment is no more than 1 month old at the time of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment
PBS-IN-WRITING/ Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has an externally draining enterocutaneous or rectovaginal fistula; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the most recent fistula assessment is no more than 1 month old at the time of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatmentPBS-IN-WRITING/PBS-BY-TELEPHONE/ Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician as specified above, of a patient with complex refractory fistulising Crohn disease who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

 Compliance with Authority Required procedures
C3697 P3697

Fistulising Crohn disease — initial treatment 3

(previous adalimumab treatment non-PBS-subsidised)
PBS-IN-WRITING/ Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria:
(a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with adalimumab prior to 4 November 2010; and
(b) had a draining enterocutaneous or rectovaginal fistula(e) prior to commencing treatment with adalimumab; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) is receiving treatment with adalimumab at the time of application; and
(e) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current and baseline Fistula Assessment form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the current fistula assessment is no more than 1 month old at the time of application;
the baseline fistula assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under this restriction once only
PBS-IN-WRITING/ Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria:
(a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with adalimumab prior to 4 November 2010; and
(b) had a draining enterocutaneous or rectovaginal fistula(e) prior to commencing treatment with adalimumab; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) is receiving treatment with adalimumab at the time of application; and
(e) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current and baseline Fistula Assessment form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the current fistula assessment is no more than 1 month old at the time of application;
the baseline fistula assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under this restriction once onlyPBS-IN-WRITING/PBS-BY-TELEPHONE/ Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of complex refractory fistulising Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

 Compliance with Authority Required procedures
C3747 P3747

Fistulising Crohn disease — initial treatment 2

(change or recommencement of PBS-subsidised treatment)
PBS-IN-WRITING/ Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or infliximab for a draining enterocutaneous or rectovaginal fistula; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where TNF-alfa antagonist means adalimumab or infliximab; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment;
the most recent fistula assessment is no more than 1 month old at the time of application;
to demonstrate a response to treatment the application must be accompanied by the results of the patient's most recent course of TNF-alfa antagonist therapy;
the assessment of response to the most recent course of TNF-alfa antagonist therapy must:
(a) be provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) have been made following a minimum of 12 weeks of treatment if the course of therapy was a 16-week initial course of adalimumab, and up to 12 weeks after the first dose (6 weeks following the third dose) if the course of therapy was a 3 dose initial course of infliximab;
if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment
PBS-IN-WRITING/ Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or infliximab for a draining enterocutaneous or rectovaginal fistula; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where TNF-alfa antagonist means adalimumab or infliximab; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment;
the most recent fistula assessment is no more than 1 month old at the time of application;
to demonstrate a response to treatment the application must be accompanied by the results of the patient's most recent course of TNF-alfa antagonist therapy;
the assessment of response to the most recent course of TNF-alfa antagonist therapy must:
(a) be provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) have been made following a minimum of 12 weeks of treatment if the course of therapy was a 16-week initial course of adalimumab, and up to 12 weeks after the first dose (6 weeks following the third dose) if the course of therapy was a 3 dose initial course of infliximab;
if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatmentPBS-IN-WRITING/PBS-BY-TELEPHONE/ Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician as specified above, of a patient who has a documented history of complex refractory fistulising Crohn disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

 Compliance with Authority Required procedures
C3748 P3748

Fistulising Crohn disease — continuing treatment

PBS-IN-WRITING/ Continuing PBS-subsidised treatment with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition;
the fistula assessment is no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response
PBS-IN-WRITING/ Continuing PBS-subsidised treatment with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition;
the fistula assessment is no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the responsePBS-IN-WRITING/PBS-BY-TELEPHONE/ Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of complex refractory fistulising Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C8547 P8547

Complex refractory Fistulising Crohn disease

Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy following a minimum of 12 weeks of therapy.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.

 Compliance with Written Authority Required procedures
C8567 P8567

Complex refractory Fistulising Crohn disease

Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug for this condition.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy following a minimum of 12 weeks of therapy.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.
A maximum of 24 weeks treatment will be authorised under this restriction.

 Compliance with Written Authority Required procedures
C8587 P8587

Complex refractory Fistulising Crohn disease

Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 1 month old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

 Compliance with Written Authority Required procedures
C8594 P8594

Complex refractory Fistulising Crohn disease

Initial 1 (new patient or Recommencement of treatment after more than 5 years break in therapy), Initial 2 (Change or Re-commencement of treatment after a break in therapy of less than 5 years) - Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

 Compliance with Authority Required procedures
C8608 P8608

Complex refractory Fistulising Crohn disease

Continuing treatment - balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Axitinib

(a)omit:

C5733 P5733

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria In Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
Prescribers may request an increased maximum quantity sufficient to provide up to one month's supply for patients who require dose adjustment.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C8588 P8588

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
Prescribers may request an increased maximum quantity sufficient to provide up to one month's supply for patients who require dose adjustment.

 Compliance with Authority Required procedures

  1. Schedule 4, after entry for Bicalutamide

insert:

Bictegravir with emtricitabine with tenofovir alafenamide C4470

HIV infection

Continuing
Patient must have previously received PBS-subsidised therapy for HIV infection.

 Compliance with Authority Required procedures - Streamlined Authority Code 4470
C4522

HIV infection

Initial
Patient must be antiretroviral treatment naive.

 Compliance with Authority Required procedures - Streamlined Authority Code 4522

  1. Schedule 4, Part 1, entry for Cabozantinib

omit entry for circumstances code “C7639” and substitute:

C8572 P8572

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 8572

  1. Schedule 4, Part 1, entry for Everolimus

(a)omit:

C4604 P4604

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria In Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus.
Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C8622 P8622

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus.
Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Guanfacine

substitute:

Guanfacine C8544

Attention deficit hyperactivity disorder

Initial treatment
Must be treated by a paediatrician or psychiatrist.
The condition must be or have been diagnosed according to the DSM-5 criteria; AND
Patient must be receiving a maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine) which has been stable for at least four weeks; AND
The treatment must be adjunctive to ongoing maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine); AND
Patient must be experiencing residual moderate to severe ADHD symptoms resulting in impaired functioning (social, academic or occupational), present in at least one setting (home, nursery/school/college/work, friends or family homes or other environment).
Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.

 Compliance with Authority Required procedures - Streamlined Authority Code 8544
C8564

Attention deficit hyperactivity disorder

Must be treated by a paediatrician or psychiatrist.
The condition must be or have been diagnosed according to the DSM-5 criteria; AND
Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; OR
Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; OR
Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR
Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously).
Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.

 Compliance with Authority Required procedures - Streamlined Authority Code 8564
C8585

Attention deficit hyperactivity disorder

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be adjunctive to ongoing maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine).

 Compliance with Authority Required procedures - Streamlined Authority Code 8585

  1. Schedule 4, Part 1, entry for Ipilimumab

insert in numerical order after existing text:

C8555

Stage IV clear cell variant renal cell carcinoma (RCC)

Induction treatment
The condition must not have previously been treated; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 8555
C8569

Stage IV clear cell variant renal cell carcinoma (RCC)

Induction treatment - Grandfather patients
Patient must have received less than 4 doses of combined therapy with ipilimumab and nivolumab as induction therapy for this condition prior to 1 March 2019; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
The condition must not have previously been treated prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
The treatment must be in combination with PBS-subsidised-treatment with nivolumab as induction for this condition; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition.
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.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 8569

  1. Schedule 4, Part 1, entry for Ixekizumab

insert in numerical order after existing text:

C8562 P8562

Severe psoriatic arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break in therapy of 5 years or more)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received prior PBS-subsidised treatment with a biological medicine for this condition; OR
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition in the previous 5 years; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 20 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide 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.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in 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 issued in this cycle and the date of the first application under a new cycle.

 Compliance with Written Authority Required procedures
C8583 P8583

Severe psoriatic arthritis

Initial treatment - Initial 1 (new patient or recommencement of treatment after more than 5 years break in therapy ) or Initial 2 (change or recommencement of treatment after a break in therapy of less than 5 years) - balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or recommencement of treatment after more than 5 years break in therapy) restriction to complete 20 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in therapy of less than 5 years) restriction to complete 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.
Patient must be aged 18 years or older.

 Compliance with Authority Required procedures
C8591 P8591

Severe psoriatic arthritis

Initial treatment - Initial 2 (change or recommencement of treatment after a break in therapy of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
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 failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 20 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
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.
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for continuing treatment, must be conducted no later than 1 month from the date of completion of this initial course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was accessed under the continuing treatment restriction, the patient must have been assessed for response, and the assessment conducted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to 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.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in 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 issued in this cycle and the date of the first application under a new cycle.

 Compliance with Written Authority Required procedures
C8592 P8592

Severe psoriatic arthritis

Continuing treatment or Grandfathered patients - balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be aged 18 years or older.

 Compliance with Authority Required procedures
C8602 P8602

Severe psoriatic arthritis

Initial treatment - Initial 3 (Grandfather patients)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 March 2019; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have demonstrated an adequate response following at least 12 weeks of non-PBS subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all continuing treatment applications.
The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response to treatment with this drug.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) the date of commencement of this drug; and
(4) results of the baseline patient assessment prior to initiation of non-PBS subsidised therapy with this drug.

 Compliance with Written Authority Required procedures
C8612 P8612

Severe psoriatic arthritis

Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all continuing treatment applications.
An application for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in 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 issued in this cycle and the date of the first application under a new cycle.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Lenvatinib

(a)insert in the column headed “Purposes Code” for the circumstance code “C6578”: P6578

(b)insert in the column headed “Purposes Code” for the circumstance code “C6604”: P6604

(c)insert in numerical order after existing text:

C8584 P8584

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Continuing treatment
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; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 8584
C8593 P8593

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not be suitable for transarterial chemoembolisation; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have Child Pugh class A; AND
Patient must not have received prior treatment with a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) for this condition; OR
Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.

 Compliance with Authority Required procedures - Streamlined Authority Code 8593
C8618 P8618

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Initial treatment - grandfathered patients
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 March 2019; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not be suitable for transarterial chemoembolisation; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have Child Pugh class A.
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 - Streamlined Authority Code 8618

  1. Schedule 4, Part 1, entry for Nivolumab

(a)omit:

C6988

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial Treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; OR
Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6988
C6993

Stage IV clear cell variant renal cell carcinoma (RCC)

Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 6993

(b)insert in numerical order after existing text:

C8552

Stage IV clear cell variant renal cell carcinoma (RCC)

Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 8552
C8568

Stage IV clear cell variant renal cell carcinoma (RCC)

Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS subsidised treatment with this drug for this condition.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 8568
C8571

Stage IV clear cell variant renal cell carcinoma (RCC)

Grandfather patients
Patient must have received less than 4 doses of combined therapy with ipilimumab and nivolumab as induction therapy for this condition prior to 1 March 2019; OR
Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 March 2019; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
The condition must not have previously been treated prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; OR
Patient must not have developed disease progression while being treated with monotherapy with nivolumab as maintenance for this condition; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition; OR
The treatment must be as monotherapy as maintenance for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 8571
C8573

Stage IV clear cell variant renal cell carcinoma (RCC)

Induction treatment
The condition must not have previously been treated; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 8573
C8581

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial Treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; OR
Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 8581

  1. Schedule 4, Part 1, entry for Pazopanib

(a)omit:

C4148 P4148

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
Patient must meet the Memorial Sloan Kettering Cancer Centre (MSKCC) low to intermediate risk group criteria; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
Patients who have progressive disease on sunitinib are not eligible to receive PBS-subsidised pazopanib.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C8551 P8551

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
Patients who have progressive disease on sunitinib are not eligible to receive PBS-subsidised pazopanib.

 Compliance with Authority Required procedures

  1. Schedule 4, entry for Pembrolizumab

insert in numerical order after existing text:

C8542

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer

Grandfathering treatment
Patient must have received non-PBS treatment with this drug for this condition prior to 1 March 2019; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy prior to initiating treatment with this drug for this condition; OR
The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer prior to initiating treatment with this drug for this condition; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer prior to initiating treatment with this drug for this condition; AND
Patient must have a WHO performance status of 2 or less prior to initiating treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed 35 cycles in total or up to 24 months of treatment, at a dose of 200 mg every 3 weeks with this drug for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 8542
C8543

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer

Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed 35 cycles in total or up to 24 months of treatment, at a dose of 200 mg every 3 weeks with this drug for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 8543
C8563

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer

Initial treatment
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy; OR
The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not exceed a total of 7 doses at a maximum dose of 200 mg every 3 weeks for this condition under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 8563

  1. Schedule 4, Part 1, entry for Ribociclib

(a)omit:

C7731 P7731

Locally advanced or metastatic breast cancer

Initial treatment
Patient must not have previously been treated with an aromatase inhibitor; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole; AND
Patient must require dosage reduction requiring a pack of 21 tablets.
Patient must not be premenopausal.

 Compliance with Authority Required procedures
C7739 P7739

Locally advanced or metastatic breast cancer

Initial treatment
Patient must not have previously been treated with an aromatase inhibitor; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole; AND
Patient must require dosage reduction requiring a pack of 42 tablets.
Patient must not be premenopausal.

 Compliance with Authority Required procedures
C7752 P7752

Locally advanced or metastatic breast cancer

Initial treatment
Patient must not have previously been treated with an aromatase inhibitor; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole.
Patient must not be premenopausal.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C8556 P8556

Locally advanced or metastatic breast cancer

Initial treatment
Patient must not have previously been treated with an aromatase inhibitor for advanced or metastatic breast cancer; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole; AND
Patient must require dosage reduction requiring a pack of 21 tablets.
Patient must not be premenopausal.

 Compliance with Authority Required procedures
C8557 P8557

Locally advanced or metastatic breast cancer

Initial treatment
Patient must not have previously been treated with an aromatase inhibitor for advanced or metastatic breast cancer; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole; AND
Patient must require dosage reduction requiring a pack of 42 tablets.
Patient must not be premenopausal.

 Compliance with Authority Required procedures
C8599 P8599

Locally advanced or metastatic breast cancer

Initial treatment
Patient must not have previously been treated with an aromatase inhibitor for advanced or metastatic breast cancer; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole.
Patient must not be premenopausal.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Rivaroxaban

insert in the column headed “Purposes Code” for the circumstance code “C4132”:  P4132

  1. Schedule 4, Part 1, entry for Sorafenib

(a)omit:

C4230 P4230

Advanced Barcelona Clinic Liver Cancer Stage C hepatocellular carcinoma

Initial
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have Child Pugh class A.

 Compliance with Authority Required procedures - Streamlined Authority Code 4230
C4234 P4234

Advanced Barcelona Clinic Liver Cancer Stage C hepatocellular carcinoma

Continuing
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been treated with PBS-subsidised sorafenib; AND
Patient must not have progressive disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 4234
C4841 P4841

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria In Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C8616 P8616

Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have Child Pugh class A; AND
Patient must not have received prior treatment with a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) for this condition; OR
Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.

 Compliance with Authority Required procedures - Streamlined Authority Code 8616
C8617 P8617

Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Continuing treatment
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; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 8617
C8621 P8621

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Sunitinib

(a)omit:

C4119 P4119

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
Patient must meet the Memorial Sloan Kettering Cancer Centre (MSKCC) low to intermediate risk group criteria; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
Patients who have developed progressive disease on pazopanib are not eligible to receive PBS-subsidised sunitinib.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C8549 P8549

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment
The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
Patients who have developed progressive disease on pazopanib are not eligible to receive PBS-subsidised sunitinib.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Tiotropium

(a) omit:

C6777

Severe asthma

Patient must have experienced at least one severe exacerbation, which has required documented use of systemic corticosteroids, in the previous 12 months while receiving optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated.
Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.

(b) insert in numerical order after existing text:

C8605

Severe asthma

Patient must have experienced at least one severe exacerbation, which has required documented use of systemic corticosteroids, in the previous 12 months while receiving optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated.
Patient must be aged 18 years or older.
Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.
C8606

Severe asthma

Must be treated by a respiratory physician, paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma; or in consultation with one of these specialists.
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must have experienced at least one severe exacerbation prior to receiving PBS-subsidised treatment with this drug for this condition, which has required documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy; OR
Patient must have experienced frequent episodes of moderate asthma exacerbations prior to receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated.
Patient must be aged 6 to 17 years inclusive.
Optimised asthma therapy includes adherence to the maintenance combination of a medium to high dose ICS and a LABA. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative

 Compliance with Authority Required procedures - Streamlined Authority Code 8606

  1. Schedule 4, after entry for Vemurafenib

insert:

Venetoclax C8565

Chronic lymphocytic leukaemia (CLL)

Initial treatment - Extension of dose titration
Patient must have experienced a treatment interruption during the PBS-subsidised dose titration with this drug for this condition; OR
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; OR
The treatment must be used as monotherapy for this condition under this restriction.

Compliance with Authority Required procedures
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
C8586

Chronic lymphocytic leukaemia (CLL)

Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with rituximab for up to a maximum of 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.

Compliance with Authority Required procedures
C8607

Chronic lymphocytic leukaemia (CLL)

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

Compliance with Authority Required procedures

  1. Schedule 5, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL [GRP-17614]

omit from the column headed “Brand”:   DEZTRON

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