National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 11) (PB 97 of 2016) (Cth)

Case

PB 97 of 2016

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 11)

National Health Act 1953

I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated        28th  November          2016

PENNY SHAKESPEARE
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health


1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2016 (No. 11).

(2)        This Instrument may also be cited as PB 97 of 2016.

2          Commencement

This Instrument commences on 1 December 2016.

3          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 Aciclovir in the form Tablet 200 mg [Maximum Quantity: 50; Number of Repeats: 0]

    omit:

a Lovir GN MP NP C5936 C5942 P5936 50 0 25

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

    (a)omit from the column headed “Responsible Person” for the brand “Lovir”:              GN          substitute:             EA

    (b)omit from the column headed “Circumstances” for the brand “Lovir”:       C5936

    (c)omit from the column headed “Purposes” for the brand “Lovir”:                 P5942

  2. 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]

    insert in the column headed “Circumstances”:            C6571 C6575 C6579 C6602 C6614 C6615

  3. 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)insert in the column headed “Circumstances”:  C6571 C6575 C6579 C6602 C6614 C6615

    (b)insert in the column headed “Purposes”:            P6575 P6602 P6615

  4. 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)insert in the column headed “Circumstances”:  C6571 C6575 C6579 C6602 C6614 C6615

    (b)omit from the column headed “Purpose”:           C6445 C6458     substitute: P6445 P6458

  5. 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]

    insert in the column headed “Circumstances”:            C6571 C6575 C6579 C6602 C6614 C6615

  6. 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)insert in the column headed “Circumstances”:  C6571 C6575 C6579 C6602 C6614 C6615

    (b)omit from the column headed “Purpose”:           C6439

    (c)insert in the column headed “Purposes”:            P6439P6571 P6579 P6614

  7. 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]

    insert in the column headed “Circumstances”:            C6571 C6575 C6579 C6602 C6614 C6615

  8. 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)insert in the column headed “Circumstances”:  C6571 C6575 C6579 C6602 C6614 C6615

    (b)insert in the column headed “Purposes”:            P6575 P6602 P6615

  9. 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)insert in the column headed “Circumstances”:  C6571 C6575 C6579 C6602 C6614 C6615

    (b)omit from the column headed “Purpose”:           C6445 C6458     substitute: P6445 P6458

  10. 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]

    insert in the column headed “Circumstances”:            C6571 C6575 C6579 C6602 C6614 C6615

  11. 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)insert in the column headed “Circumstances”:  C6571 C6575 C6579 C6602 C6614 C6615

    (b)omit from the column headed “Purpose”:           C6439

    (c)insert in the column headed “Purposes”:            P6439P6571 P6579 P6614

  12. Schedule 1, entry for Adalimumab in the form injection 40 mg in 0.8 mL pre-filled syringe, 6

    insert in the column headed “Circumstances”:            C6575 C6602 C6615

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

    insert in the column headed “Circumstances”:            C6575 C6602 C6615

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

    (a)omit from the column headed “Circumstances”:               C6530 C6541

    (b)insert in numerical order the column headed “Circumstances”:   C6567 C6574 C6594 C6599

    (c)omit from the column headed “Purposes”:         P6530 P6541

    (d)insert in numerical order in the column headed “Purposes”:         P6567 P6574 P6594 P6599

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

    (a)omit from the column headed “Circumstances”:               C6530 C6541

    (b)insert in numerical order the column headed “Circumstances”:   C6567 C6574 C6594 C6599

  16. Schedule 1, omit entry for Alginic acid with calcium carbonate and sodium bicarbonate

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

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

    (b)substitute for the brand “Progout 100”:

a Progout 100 AF MP NP 200 2 100
MP NP 200 2 200

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

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

    (b)omit from the column headed “Brand”:               Amlodipine generichealth           substitute:             Amlodipine GH

  1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

    (a)omit:

Bgramin FM PDP 1 0 1

(b)omit:

Bgramin FM MP NP 1 1 1

  1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

    (a)omit:

Bgramin FM PDP 1 0 1

(b)omit:

Bgramin FM MP NP 1 1 1

  1. Schedule 1, after entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL

    insert in the columns in the order indicated:

Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre-filled syringe Injection Movapo PFS TD MP C4833 C4860 180 5 5 D(100)

  1. Schedule 1, entry for Aripiprazole

    omit:

Aripiprazole Tablet 10 mg Oral Abilify OS MP NP C4246 30 5 30
Tablet 15 mg Oral Abilify OS MP NP C4246 30 5 30
Tablet 20 mg Oral Abilify OS MP NP C4246 30 5 30
Tablet 30 mg Oral Abilify OS MP NP C4246 30 5 30

substitute:

Aripiprazole Tablet 10 mg Oral a Abilify OS MP NP C4246 30 5 30
a Aripiprazole GH GQ MP NP C4246 30 5 30
a Aripiprazole Sandoz SZ MP NP C4246 30 5 30
Tablet 15 mg Oral a Abilify OS MP NP C4246 30 5 30
a Aripiprazole GH GQ MP NP C4246 30 5 30
a Aripiprazole Sandoz SZ MP NP C4246 30 5 30
Tablet 20 mg Oral a Abilify OS MP NP C4246 30 5 30
a Aripiprazole GH GQ MP NP C4246 30 5 30
a Aripiprazole Sandoz SZ MP NP C4246 30 5 30
Tablet 30 mg Oral a Abilify OS MP NP C4246 30 5 30
a Aripiprazole GH GQ MP NP C4246 30 5 30
a Aripiprazole Sandoz SZ MP NP C4246 30 5 30

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

    (a)omit:

a Atorvastatin Pfizer FZ MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

a Atorvastatin Pfizer FZ MP C4238 C4263 P4238 30 11 30

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

    (a)omit:

a Atorvastatin Pfizer FZ MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

a Atorvastatin Pfizer FZ MP C4238 C4263 P4238 30 11 30

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

    (a)omit:

a Atorvastatin Pfizer FZ MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

a Atorvastatin Pfizer FZ MP C4238 C4263 P4238 30 11 30

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

    (a)omit:

a Atorvastatin Pfizer FZ MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

a Atorvastatin Pfizer FZ MP C4238 C4263 P4238 30 11 30

  1. Schedule 1, entry for Bivalirudin

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

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

a Bivalirudin APOTEX TX MP C4919 1 0 1

  1. Schedule 1, entry for Buprenorphine

    (a)omit:

Transdermal patch 5 mg Transdermal Norspan MF MP NP C4951 2 0 2
Transdermal patch 10 mg Transdermal Norspan MF MP NP C4951 2 0 2
Transdermal patch 15 mg Transdermal Norspan MF MP NP C4951 2 0 2
Transdermal patch 20 mg Transdermal Norspan MF MP NP C4951 2 0 2
Transdermal patch 25 mg Transdermal Norspan MF MP NP C4951 2 0 2
Transdermal patch 30 mg Transdermal Norspan MF MP NP C4951 2 0 2
Transdermal patch 40 mg Transdermal Norspan MF MP NP C4951 2 0 2

(b)substitute:

Transdermal patch 5 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 10 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 15 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 20 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 25 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 30 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 40 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2

  1. Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg

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

a CANDESAN RF MP NP 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

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

a CANDESAN COMBI 16/12.5 RF MP NP C4374 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

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

a CANDESAN COMBI 32/12.5 RF MP NP C4374 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

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

a CANDESAN COMBI 32/25 RF MP NP C4374 30 5 30

  1. Schedule 1, entry for Capecitabine in the form Tablet 500 mg

    omit:

Capecitabine GH GQ MP 120 2 120

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

    omit:

Kudeq FZ MP NP C4907 C4962 60 3 60

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

    omit:

Kudeq FZ MP NP C4907 C4962 30 3 30

  1. Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)

    omit:

Citalopram generichealth GQ MP NP C4755 28 5 28

  1. Schedule 1, entry for Entecavir

    substitute:

Entecavir Tablet 0.5 mg (as monohydrate) Oral a Baraclude BQ MP C4993 C5036 60 5 30 D(100)
a Entecavir Amneal EA MP C4993 C5036 60 5 30 D(100)
a Entecavir APOTEX TX MP C4993 C5036 60 5 30 D(100)
a Entecavir Mylan AF MP C4993 C5036 60 5 30 D(100)
a ENTECAVIR RBX RA MP C4993 C5036 60 5 30 D(100)
a Entecavir Sandoz SZ MP C4993 C5036 60 5 30 D(100)
a ENTECLUDE RW MP C4993 C5036 60 5 30 D(100)
Tablet 1 mg (as monohydrate) Oral a Baraclude BQ MP C5037 C5044 60 5 30 D(100)
a Entecavir Amneal EA MP C5037 C5044 60 5 30 D(100)
a Entecavir APOTEX TX MP C5037 C5044 60 5 30 D(100)
a Entecavir Mylan AF MP C5037 C5044 60 5 30 D(100)
a ENTECAVIR RBX RA MP C5037 C5044 60 5 30 D(100)
a Entecavir Sandoz SZ MP C5037 C5044 60 5 30 D(100)
a ENTECLUDE RW MP C5037 C5044 60 5 30 D(100)

  1. Schedule 1, entry for Erythromycin

    omit:

Powder for I.V. infusion 1 g (as lactobionate) Injection Erythrocin‑I.V. ZC MP NP PDP 5 0 1

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

    insert:

Evolocumab Injection 140 mg in 1 mL single use pre-filled pen Injection Repatha AN MP C6586 C6597 C6608 3 5 1

  1. Schedule 1, entry for Exemestane

    omit:

Exemestane Pfizer FZ MP C4796 C5522 30 5 30
NP C5522 30 5 30

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

    insert:

Tablet 250 mg, 30 Oral Flutamide MYLAN AF MP NP C6611 3 5 1

  1. Schedule 1, entry for Fosinopril in each of the forms: Tablet containing fosinopril sodium 10 mg; and Tablet containing fosinopril sodium 20 mg

    omit:

Monopril BQ MP NP 30 5 30

  1. Schedule 1, entry for Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg

    omit:

Monoplus 20/12.5 BQ MP NP C4389 30 5 30

  1. Schedule 1, omit entry for Homatropine

  1. Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]

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

Imatinib-APOTEX TX MP C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 60 2 60

  1. Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 5]

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

Imatinib-APOTEX TX MP C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 P6495 P6509 P6525 60 5 60

  1. Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]

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

Imatinib-APOTEX TX MP C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 30 2 30

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

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

Imatinib-APOTEX TX MP C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 P6495 P6509 P6525 30 5 30

  1. Schedule 1, entry for Ipilimumab in each of the forms: Injection concentrate for I.V. infusion 50 mg in 10 mL; and Injection concentrate for I.V. infusion 200 mg in 40 mL

    omit from the column headed “Circumstances”:          C4254 C4261      substitute:             C6562 C6585

  2. Schedule 1, entry for Itraconazole in the form Capsule 100 mg

    substitute:

Capsule 100 mg Oral a APO-Itraconazole TX MP NP C5988 C6005 C6016 C6022 C6035 C6037 C6057 60 5 60
a Itracap AF MP NP C5988 C6005 C6016 C6022 C6035 C6037 C6057 60 5 60
a ITRANOX RW MP NP C5988 C6005 C6016 C6022 C6035 C6037 C6057 60 5 60
a Sporanox JC MP NP C5988 C6005 C6016 C6022 C6035 C6037 C6057 60 5 60

  1. Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

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

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

a LAMITAN RF MP NP C5138 56 5 56

  1. Schedule 1, entry for Latanoprost

    omit:

Latanoprost Pfizer FZ MP AO 1 5 1

  1. Schedule 1, entry for Latanoprost with timolol

    omit:

Latanocom FZ MP C4343 1 5 1
AO C5038 1 5 1

  1. Schedule 1, after entry for Lenograstim in the form Powder for injection 33,600,000 I.U. (263 micrograms)

    insert:

Lenvatinib Capsule 4 mg (as mesilate) Oral Lenvima EI MP C6577 C6578 C6604 30 2 30
Capsule 10 mg (as mesilate) Oral Lenvima EI MP C6577 C6578 C6604 60 2 30

  1. Schedule 1, after entry for Leuprorelin in the form Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set

    insert:

Leuprorelin and bicalutamide Pack containing 1 syringe containing leuprorelin 7.5 mg (as acetate) and 28 tablets bicalutamide 50 mg Injection/oral Bi ELIGARD CP TL MP C4895 1 5 1
Pack containing 1 syringe containing leuprorelin 22.5 mg (as acetate) and 28 tablets bicalutamide 50 mg Injection/oral Bi ELIGARD CP TL MP C4895 1 0 1
Pack containing 1 syringe containing leuprorelin 22.5 mg (as acetate) and 84 tablets bicalutamide 50 mg Injection/oral Bi ELIGARD CP TL MP C4895 1 1 1

  1. Schedule 1, entry for Lignocaine in the form Infusion containing lignocaine hydrochloride 500 mg in 5 mL

    omit from the column headed “Responsible Person”:                 AP        substitute:             AS

  1. Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

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

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

a Blooms the Chemist Metformin XR 500 IB MP NP 120 5 120

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

a Metformin XR 500 APOTEX GX MP NP 120 5 120

  1. Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

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

a Blooms the Chemist Metformin XR 1000 IB MP NP 60 5 60

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

a Chem mart Metformin XR 1000 CH MP NP 60 5 60

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

a Terry White Chemists Metformin XR 1000 TW MP NP 60 5 60

  1. Schedule 1, after entry for Obinutuzumab

    insert:

Ocriplasmin Solution concentrate for intravitreal injection 0.5 mg in 0.2 mL Injection Jetrea NV MP C6601 1 0 1

  1. Schedule 1, entry for Olmesartan

    substitute:

Olmesartan Tablet containing olmesartan medoxomil 20 mg Oral a Olmesartan - MYL AF

MP NP

 30 5 30
a Olmetec MK

MP  NP

 30 5 30
Tablet containing olmesartan medoxomil 40 mg Oral a Olmesartan - MYL AF

MP NP

 30 5 30
a Olmetec MK MP NP 30 5 30

  1. Schedule 1, entry for Olmesartan with amlodipine

    substitute:

Olmesartan with amlodipine Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besylate) Oral a Olmesartan/Amlodipine - MYL 20/5 AF MP NP C4373 30 5 30
a Sevikar 20/5 MK MP NP C4373 30 5 30
Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate) Oral a Olmesartan/Amlodipine - MYL 40/5 AF MP NP C4373 30 5 30
a Sevikar 40/5 MK MP NP C4373 30 5 30
Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate) Oral a Olmesartan/Amlodipine - MYL 40/10 AF MP NP C4373 30 5 30
a Sevikar 40/10 MK MP NP C4373 30 5 30

  1. Schedule 1, entry for Olmesartan with Hydrochlorothiazide

    substitute:

Olmesartan with hydrochlorothiazide Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg Oral a Olmesartan HCT - MYL 20/12.5 AF MP NP C4374 30 5 30
a Olmetec Plus MK MP NP C4374 30 5 30
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg Oral a Olmesartan HCT - MYL 40/12.5 AF MP NP C4374 30 5 30
a Olmetec Plus MK MP NP C4374 30 5 30
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg Oral a Olmesartan HCT - MYL 40/25 AF MP NP C4374 30 5 30
a Olmetec Plus MK MP NP C4374 30 5 30

  1. Schedule 1, entry for Oxybutynin in the form Transdermal patches 36 mg, 8

    omit from the column headed “Responsible Person”:                 AG       substitute:             GN

  2. Schedule 1, entry for Quetiapine in the form Tablet (modified release) 150 mg (as fumarate)

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

a QUEPINE XR RW MP NP C4246 C5611 C5639 60 5 60

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

  1. Schedule 1, entry for Ramipril in each of the forms: Tablet 2.5 mg; Tablet 5 mg; and Tablet 10 mg

    omit:

Ramipril RBX Tabs RA MP NP 30 5 30

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

    (a)omit from the column headed “Circumstances”:               C6511 C6529

    (b)insert in numerical order the column headed “Circumstances”:   C6570 C6581

    (c)omit from the column headed “Purposes”:         P6511 P6529

    (d)insert in numerical order in the column headed “Purposes”:         P6570 P6581

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

    (a)omit from the column headed “Circumstances”:               C6511 C6529

    (b)insert in numerical order the column headed “Circumstances”:   C6570 C6581

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

    (a)omit from the column headed “Circumstances”:               C6511 C6529

    (b)insert in numerical order the column headed “Circumstances”:   C6570 C6581

    (c)omit from the column headed “Purposes”:         P6511 P6529

    (d)insert in numerical order in the column headed “Purposes”:         P6570 P6581

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

    (a)omit from the column headed “Circumstances”:               C6511 C6529

    (b)insert in numerical order the column headed “Circumstances”:   C6570 C6581

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

    (a)omit:

a Risperidone GH GQ MP NP C5902 C5903  C5911 C6010 P5902 P5911 P6010 60 2 60

(b)omit:

a Risperidone GH GQ MP NP C5902 C5903 C5911 C6010 P5903 60 5 60

  1. Schedule 1, entry for Rivastigmine in the form Transdermal patch 9 mg

    (a)insert in the column headed “Schedule Equivalent” for the brand “Exelon Patch 5”:            a

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

a Rivastigmelon Patch 5 AF MP NP C4219 C4220 C4224 30 5 30

  1. Schedule 1, entry for Rivastigmine in the form Transdermal patch 18 mg

    (a)insert in the column headed “Schedule Equivalent” for the brand “Exelon Patch 10”:          a

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

a Rivastigmelon Patch 10 AF MP NP C4219 C4220 C4224 30 5 30

  1. Schedule 1, entry for Sorbitol with sodium citrate and sodium lauryl sulfoacetate

    substitute:

Sorbitol with sodium citrate and sodium lauryl sulfoacetate Enemas 3.125 g‑450 mg‑45 mg in 5 mL, 12 Rectal Micolette AE MP NP C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139 P5613 P5640 P5685 P5720 P5775 P5776 P5804 2 2 1
MP NP C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139 P6139 2 3 1
MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)

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

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

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

a Temozolomide Amneal ED MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

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

a Temozolomide Amneal ED MP P4897 15 2 5

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

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

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

a Temozolomide Amneal ED MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

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

a Temozolomide Amneal ED MP P4897 15 2 5

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

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

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

a Temozolomide Amneal ED MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

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

a Temozolomide Amneal ED MP P4897 15 2 5

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

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

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

a Temozolomide Amneal ED MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

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

a Temozolomide Amneal ED MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 250 mg

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

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

a Temozolomide Amneal ED MP 5 5 5

  1. Schedule 1, entry for Tenofovir with Emtricitabine

    insert as first items in the columns in the order indicated:        

Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg Oral Descovy 10/200 GI MP C4454 C4512 60 5 30 D(100)
Tablet containing tenofovir alafenamide 25 mg with emtricitabine 200 mg Oral Descovy 25/200 GI MP C4454 C4512 60 5 30 D(100)

  1. Schedule 1, entry for Terbinafine in the form Cream containing terbinafine hydrochloride 10 mg per g, 15 g

    omit from the column headed “Responsible Person”:                 NC        substitute:             GK

  2. Schedule 1, entry for Testosterone in each of the forms: Transdermal patches 12.2 mg, 60; and Transdermal patches 24.3 mg, 30

    omit from the column headed “Responsible Person”:                 AG       substitute:             GN

  3. Schedule 1, entry for Tocilizumab

    omit from the column headed “Section 100/Prescriber Bag only” (all instances):              D(100)   substitute:             PB(100)

  4. Schedule 1, after entry for Tocilizumab in the form Concentrate for injection 400 mg in 20 mL

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

Injection 162 mg in 0.9 mL single use pre-filled syringe Injection Actemra Subcutaneous Injection RO MP C6573 C6593 C6605 C6606 C6610 P6573 P6593 P6605 4 3 4
MP C6573 C6593 C6605 C6606 C6610 P6606 P6610 4 5 4

  1. Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5mL [Maximum Quantity: 1; Number of Repeats: 1]

    (a)omit from the column headed “Circumstances”:               C6508   substitute:             C6588

    (b)omit from the column headed “Purposes”:         P6508   substitute:             P6588

  2. Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5mL [Maximum Quantity: 1; Number of Repeats: 2]

    omit from the column headed “Circumstances”:          C6508   substitute:             C6588

  3. Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)

    omit:

Altven FZ MP NP C5650 28 0 28

  1. Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)

    omit:

Altven FZ MP NP C5650 28 5 28

  1. Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 0]

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

a Vzole RW MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56

  1. Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 2]

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

a Vzole RW MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 P5748 56 2 56

  1. Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 0]

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

a Vzole RW MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56

  1. Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 2]

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

a Vzole RW MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 P5748 56 2 56

  1. Schedule 3

    omit:

NC Novartis Consumer Health Australasia Pty Ltd  46 004 535 513

  1. Schedule 4, Part 1, entry for Adalimumab

    insert in numerical order after existing text:

C6571 P6571 Moderate to severe ulcerative colitis
Balance of supply for Continuing treatment and Initial 3 (Grandfathered patients)
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient treatment with this drug to complete 24 weeks of treatment under the Initial 3 (Grandfathered patients).
Patient must be 6 years of age or older.
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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Authority approval for sufficient therapy to complete a maximum of 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services. 		Compliance with Authority Required procedures
C6575 P6575 Moderate to severe ulcerative colitis
Balance of supply for Initial 1 and Initial 2
Patient must have received insufficient treatment with this drug under the Initial 1 (new patient or recommencement of treatment after more than 5 years break in therapy) restriction to complete 16 weeks of treatment; OR
Patient must have received insufficient treatment with this drug under the Initial 2 (Change or Re-commencing of treatment after less than 5 years break in therapy) to complete 16 weeks of treatment.
Patient must be 6 years of age or older.
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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Authority approval for sufficient therapy to complete a maximum of 16 weeks of treatment may be requested by telephone by contacting the Department of Human Services. 		Compliance with Authority Required procedures
C6579 P6579 Moderate to severe ulcerative colitis
Initial 3 (Grandfathered patient)
Patient must have a documented history of moderate to severe ulcerative colitis; AND
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND
Patient must be receiving treatment with this drug at the time of application; AND
Patient must have a Mayo score greater than or equal to 6 prior to commencing treatment with this drug; OR
Patient must have a partial Mayo score is greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 prior to commencing treatment with this drug, if aged 6 to 17 years; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic, partial Mayo clinic or PUCAI baseline assessment is not available, if aged 6 to 17 years; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and baseline Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheets including the dates of assessment of the patient's condition; and (ii) the date of commencement of this drug; and (iii) the signed patient or guardian acknowledgement
The current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment must be no more than 1 month old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug. Where a baseline assessment is not available the prescriber must contact the Department of Human Services to discuss.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. 		Compliance with Written Authority Required procedures
C6602 P6602 Moderate to severe ulcerative colitis
Change or Re-commencement of treatment after a break of less than 5 years in therapy (Initial 2)
Patient must have previously received PBS-subsidised treatment with infliximab, vedolizumab or adalimumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle.
Patient must be 6 years of age or older.
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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of initial treatment must be in writing and must include:(a) a completed authority prescription form; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition.
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats. 		Compliance with Written Authority Required procedures
C6614 P6614 Moderate to severe ulcerative colitis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
All applications 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 submitted 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 submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. 		Compliance with Authority Required procedures
C6615 P6615 Moderate to severe ulcerative colitis
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years.
Patient must be 6 years of age or older.
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)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement or guardian acknowledgement.
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Aflibercept

    omit

C6530 P6530

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be due to age-related macular degeneration (AMD); AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6541 P6541

Central retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures

insert in numerical order after existing text:

C6567 P6567

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6574 P6574

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be due to age-related macular degeneration (AMD); AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6594 P6594

Central retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6599 P6599

Branch retinal vein occlusion with macular oedema

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for the same eye; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Alginic acid with calcium carbonate and sodium bicarbonate

  2. Schedule 4, Part 1, entry for Buprenorphine

    (a)insert in the column headed “Purposes Code” for Circumstances Code C4951:       P4951

    (b)insert in numerical order after existing text:

C6151 P6151

Chronic severe disabling pain

Patient must be receiving palliative care; AND

The condition must be unresponsive to non-opioid analgesics.

 Compliance with Authority Required procedures

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

    insert:

Evolocumab C6586

Familial homozygous hypercholesterolaemia

Grandfathering treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND

The treatment must be in conjunction with dietary therapy and exercise; AND

The condition must have been confirmed by genetic testing; OR

The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7; AND

Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre after at least 3 months of treatment at a maximum tolerated dose of an HMG CoA reductase inhibitor (statin), in conjunction with dietary therapy and exercise, prior to initiation of treatment with this drug; OR

Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre after having developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a withdrawal of statin treatment, prior to initiation of treatment with this drug; OR

Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre prior to initiation of treatment with this drug, and must be contraindicated to treatment with an HMG CoA reductase inhibitor (statin).

Must be treated by a consultant physician or in consultation with a consultant physician.

The date of the consultation with a consultant physician must be no more than 6 months prior to the application for a PBS authority. The full name of the consultant physician consulted and the date of consultation are to be provided at the time of application.

The qualifying LDL cholesterol level prior to initiation of treatment with this drug must be provided at the time of application. With the exception of patients contraindicated to a statin, the agent, dose and duration of statin treatment must be provided at the time of application.

A clinically important product-related adverse event is defined as follows:

(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or

(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or

(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.

The authority application must be made in writing and must include:

a) A completed authority prescription form; and

b) A completed Familial homozygous hypercholesterolaemia Initial PBS 'Grandfather' Authority Application - Supporting Information Form; and

c) The date of consultation and the full name of the consultant physician; and

d) A copy of the qualifying Dutch Lipid Clinic Network Score or a copy of the result of genetic testing; and

e) The result of LDL cholesterol level and one of the following where appropriate: statin treatment details including agent, dose and treatment duration; or details of adverse event or contraindication to treatment with a statin as defined in the TGA-approved Product Information.

 Compliance with Written Authority Required procedures
C6597

Familial homozygous hypercholesterolaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be in conjunction with dietary therapy and exercise.

 Compliance with Authority Required procedures
C6608

Familial homozygous hypercholesterolaemia

Initial treatment

The treatment must be in conjunction with dietary therapy and exercise; AND

The condition must have been confirmed by genetic testing; OR

The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7; AND

Patient must have an LDL cholesterol level in excess of 3.3 millimoles per litre after at least 3 months of treatment at a maximum tolerated dose of an HMG CoA reductase inhibitor (statin), in conjunction with dietary therapy and exercise; OR

Patient must have an LDL cholesterol level in excess of 3.3 millimoles per litre after having developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a withdrawal of statin treatment; OR

Patient must have an LDL cholesterol level in excess of 3.3 millimoles per litre and must be one in whom treatment with an HMG CoA reductase inhibitor (statin) is contraindicated.

Must be treated by a consultant physician or in consultation with a consultant physician.

A clinically important product-related adverse event is defined as follows:

(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or

(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or

(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.

The date of the consultation with a consultant physician must be no more than 6 months prior to the application for a PBS authority. The full name of the consultant physician consulted and the date of consultation are to be provided at the time of application.

The qualifying LDL cholesterol level must be provided at the time of application and must be no more than 2 months old. With the exception of patients contraindicated to a statin, the agent, dose and duration of statin treatment must be provided at the time of application.

The authority application must be made in writing and must include:

a) A completed authority prescription form; and

b) A completed Familial homozygous hypercholesterolaemia Initial PBS Authority Application - Supporting Information Form; and

c) The date of consultation and the full name of the consultant physician; and

d) A copy of the qualifying Dutch Lipid Clinic Network Score or a copy of the result of genetic testing; and

e) The result of LDL cholesterol level and one of the following where appropriate: statin treatment details including agent, dose and treatment duration; or details of adverse event or contraindication to treatment with a statin as defined in the TGA-approved Product Information.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Flutamide

    insert in numerical order after existing text:

C6611

Metastatic (stage D) carcinoma of the prostate

The treatment must be in combination with GnRH (LH-RH) analogue therapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6611

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

    omit:

C4254

Unresectable Stage III or Stage IV malignant melanoma

Induction treatment

The treatment must be as monotherapy;
Patient must not have received prior treatment with ipilimumab;
The treatment 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 4254
C4261

Unresectable Stage III or Stage IV malignant melanoma

Re‑induction treatment

The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re‑induction);
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks

An initial objective response to treatment is defined as either:

(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or

(ii) a partial or complete response

The patient’s body weight must be documented in the patient’s medical records at the time treatment with ipilimumab is initiated

 Compliance with Authority Required procedures – Streamlined Authority Code 4261

insert in numerical order after existing text:

C6562 P6562

Unresectable Stage III or Stage IV malignant melanoma

Induction treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not have received prior treatment with ipilimumab; AND

The treatment 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 6562
C6585 P6585

Unresectable Stage III or Stage IV malignant melanoma

Re-induction treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction); AND

The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.

An initial objective response to treatment is defined as either:

(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or

(ii) a partial or complete response.

The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6585

  1. Schedule 4, Part 1, after entry Lenograstim

    insert:

Lenvatinib C6577

Locally advanced or metastatic differentiated thyroid cancer

Grandfathering treatment

The condition must be refractory to radioactive iodine; AND

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have thyroid stimulating hormone adequately repressed.

 Compliance with Authority Required procedures - Streamlined Authority Code 6577
C6578

Locally advanced or metastatic differentiated thyroid cancer

Continuing treatment

The condition must be refractory to radioactive iodine; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST).

 Compliance with Authority Required procedures - Streamlined Authority Code 6578
C6604

Locally advanced or metastatic differentiated thyroid cancer

Initial treatment

The condition must be refractory to radioactive iodine; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have symptomatic progressive disease prior to treatment; OR

Patient must have progressive disease at critical sites with a high risk of morbidity or mortality where local control cannot be achieved by other measures; AND

Patient must have thyroid stimulating hormone adequately repressed; AND

Patient must be one in whom surgery is inappropriate; AND

Patient must not be a candidate for radiotherapy with curative intent; AND

Patient must have a WHO performance status of 2 or less.

Radioactive iodine refractory is defined as:

a lesion without iodine uptake on a radioactive iodine (RAI) scan; or

having received a cumulative RAI dose of greater than or equal to 600 mCi; or

progression within 12 months of a single RAI treatment; or

progression after two RAI treatments administered within 12 months of each other.

 Compliance with Authority Required procedures - Streamlined Authority Code 6604

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

    insert:

Leuprorelin and bicalutamide C4895

Carcinoma of the prostate

The condition must be metastatic (stage D); AND

Patient must require a combination of an antiandrogen and a GnRH (LH-RH) agonist.

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

    insert:

Ocriplasmin C6601

Vitreomacular traction syndrome

Patient must have visual impairment due to vitreomacular traction (VMT) without a full thickness macular hole (FTMH); OR

Patient must have visual impairment due to vitreomacular traction (VMT) with a full thickness macular hole (FTMH) of a diameter of less than or equal to 400 micrometres; AND

Patient must have documented visual impairment defined as a best corrected visual acuity score of approximate Snellen equivalent 20/25 or worse in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; AND

The condition must have a vitreomacular adhesion diameter less than or equal to 1500 micrometres; AND

Patient must not have an epiretinal membrane attached to the vitreomacular traction; AND

The condition must be previously untreated in the eye proposed for treatment; AND

Patient must not have received prior vitrectomy in the eye proposed for treatment; AND

Patient must be symptomatic.

Must be treated by an ophthalmologist.

The prescriber must state which eye(s) is being treated at the time of application.

 Compliance with Authority Required procedures

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

  2. Schedule 4, Part 1, Ranibizumab

    (a)omit:

C6511 P6511

Central retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6529 P6529

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Branched Retinal Vein Occlusion (BRVO) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Branched Retinal Vein Occlusion (BRVO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C6570 P6570

Central retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6581 P6581

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures

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

    insert:

Tocilizumab C6573 P6573

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)

Patient must have a documented history of severe active rheumatoid arthritis; AND

Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND

Patient must not receive more than 16 weeks of treatment under this restriction.

Patient must be aged 18 years or older.

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.

The authority application must be made in writing and must include:(a) completed authority prescription form(s); and(b) a completed Rheumatoid Arthritis continuing PBS Authority Application - Supporting Information Form. Applications for a patient who has received PBS-subsidised treatment with tocilizumab 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 tocilizumab treatment, within the timeframes specified below.Where the most recent course of PBS-subsidised tocilizumab treatment was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised tocilizumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab. If a patient fails to demonstrate a response to a treatment with tocilizumab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. If a patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD.

An adequate response to treatment is defined as:

an ESR no greater than 25 mm per hour or a 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 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).

 Compliance with Written Authority Required procedures
C6593 P6593

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after break of more than 24 months)

Patient must have severe active rheumatoid arthritis; AND

Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND

Patient must not have failed previous PBS-subsidised treatment with tocilizumab for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND

Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR

Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR

Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND

Patient must not receive more than 16 weeks of treatment under this restriction.

Patient must be aged 18 years or older.

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.

If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.

The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.

The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.

If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.

The authority application must be made in writing and must include:(1) completed authority prescription form(s); and(2) a completed Rheumatoid Arthritis initial PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement.If a patient fails to demonstrate a response to treatment with tocilizumab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. The following 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) a total 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). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. 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. Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.

 Compliance with Written Authority Required procedures
C6605 P6605

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply

Patient must have received insufficient tocilizumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR

Patient must have received insufficient tocilizumab therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) 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.

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.

 Compliance with Authority Required procedures
C6606 P6606

Severe active rheumatoid arthritis

Continuing treatment

Patient must have a documented history of severe active rheumatoid arthritis; AND

Patient must have demonstrated an adequate response to treatment with tocilizumab; AND

Patient must have received tocilizumab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND

Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.

Patient must be aged 18 years or older.

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.

An adequate response to treatment is defined as:

an ESR no greater than 25 mm per hour or a 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 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).

Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.

The authority application must be made in writing and must include:

(1) completed authority prescription form(s); and

(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.

All applications for continuing treatment with tocilizumab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with tocilizumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.

Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.

If a patient fails to demonstrate a response to treatment with tocilizumab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Written Authority Required procedures
C6610 P6610

Severe active rheumatoid arthritis

Continuing treatment – balance of supply

Patient must have received insufficient tocilizumab therapy 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.

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Ustekinumab

    (a)omit:

C6508 P6508

Severe psoriatic arthritis

Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) or Continuing treatment - balance of supply

Patient must have received insufficient therapy with this drug under the Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) 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.

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C6588 P6588

Severe psoriatic arthritis

Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) or Continuing treatment - balance of supply

Patient must have received insufficient therapy with this drug under the Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; OR

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.

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

 Compliance with Authority Required procedures

  1. Schedule 5, entry for Imatinib in the form Capsule 100 mg (as mesilate) [GRP-21074]

    insert in alphabetical order in the column headed “Brand”:   Imatinib-APOTEX

  2. Schedule 5, entry for Imatinib in the form Capsule 100 mg (as mesilate) [GRP-21076]

    insert in alphabetical order in the column headed “Brand”:   Imatinib-APOTEX

  3. Schedule 5, entry for Imatinib in the form Capsule 400 mg (as mesilate) [GRP-21079]

    insert in alphabetical order in the column headed “Brand”:   Imatinib-APOTEX

  4. Schedule 5, entry for Imatinib in the form Capsule 400 mg (as mesilate) [GRP-21080]

    insert in alphabetical order in the column headed “Brand”:   Imatinib-APOTEX

  5. Schedule 5, entry for Ramipril in the form Tablet 10 mg [GRP-15431]

    omit from the column headed “Brand”:         Ramipril RBX Tabs

Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0