National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 6) (PB 55 of 2015) (Cth)

Case

PB 55 of 2015

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 6)

National Health Act 1953

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

Dated 26 June   2015

FELICITY McNEILL
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 2015 (No. 6).

(2)        This Instrument may also be cited as PB 55 of 2015.

2          Commencement

This Instrument commences on 1 July 2015.

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. Section 4

    omit from the definition of “I.V.”:   mean     substitute:             means

  2. Section 4

    insert after the definition of “I.V.”:

    Medicare Benefits Schedule means the Health Insurance (General Medical Services Table) Regulations;

  3. Schedule 1, entry for Abacavir in each of the forms: Tablet 300 mg (as sulfate); and Oral solution 20 mg (as sulfate) per mL, 240 mL

    omit from the column headed “Circumstances”:       C4455  C4469

  4. Schedule 1, entry for Abacavir with Lamivudine

    (a)omit from the column headed “Circumstances”:           C4505

    (b)omit from the column headed “Circumstances”:           C4538  

  5. Schedule 1, entry for Abacavir with Lamivudine and Zidovudine

    (a)omit from the column headed “Circumstances”:           C4472

    (b)omit from the column headed “Circumstances”:           C4523

  6. Schedule 1, entry for Adefovir

    omit from the column headed “Circumstances” (twice occurring):      C3971  C3972  C3973  C3974     substitute:                C4490  C4510

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

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

Chem mart Alendronate Plus D3 70 mg/70 mcg CH MP NP C4070 C4087 C4110 4 5 4

(b)omit from the column headed “Brand”:          FonatPLUS       substitute:         FonatPlus

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

Terry White Chemists Alendronate Plus D3 70 mg/70 mcg TW MP NP C4070 C4087 C4110 4 5 4

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

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

Chem mart Alendronate Plus D3 70 mg/140 mcg CH MP NP C4122 C4123 C4133 4 5 4

(b)omit from the column headed “Brand”:               FonatPLUS       substitute:         FonatPlus

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

Terry White Chemists Alendronate Plus D3 70 mg/140 mcg TW MP NP C4122 C4123 C4133 4 5 4

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]

    (a)omit from the column headed “Responsible Person” for the brand “Clavam 875 mg/125 mg”:             NJ        substitute:    CR

    (b)omit:

Pharmacor AmoxyClav 875/125 CR PDP C1836 C1837 10 0 10

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]

    (a)omit from the column headed “Responsible Person” for the brand “Clavam 875 mg/125 mg”:             NJ        substitute:    CR

    (b)omit:

Pharmacor AmoxyClav 875/125 CR MP NP C1836 C1837 10 1 10

  1. Schedule 1, entry for Atazanavir in each of the forms: Capsule 150 mg (as sulfate); Capsule 200 mg (as sulfate); and Capsule 300 mg
    (as sulfate)

    omit from the column headed “Circumstances”:       C4455  C4469

  2. Schedule 1, entry for Bimatoprost with timolol in the form Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL

    omit from the column headed “Circumstances” [Authorised Prescriber AO]:      C4326    substitute:             C5038

  3. Schedule 1, entry for Bimatoprost with timolol in the form Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, single dose units 0.4 mL, 30

    omit from the column headed “Circumstances” [Authorised Prescriber AO]:      C4326    substitute:             C5038

  4. Schedule 1, entry for Brimonidine with timolol

    omit from the column headed “Circumstances” [Authorised Prescriber AO]:      C4326    substitute:             C5038

  5. Schedule 1, entry for Brinzolamide with timolol

    omit from the column headed “Circumstances” [Authorised Prescriber AO]:      C4326    substitute:             C5038

  6. Schedule 1, entry for Captopril in the form Oral solution 5 mg per mL, 95 mL

    omit from the column headed “Circumstances”:       C4966   substitute:             C4996

  7. Schedule 1, entry for Ceftriaxone in the form Powder for injection 500 mg (as sodium)

    (a)omit:

Ceftriaxone ICP PP MP NP C1143 C1169 C1846 C1847 P1143 1 0 1

(b)omit:

Ceftriaxone ICP PP MP NP C1143 C1169 C1846 C1847 P1169 P1846 P1847 5 0 1

  1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]

    (a)omit from the column headed “Responsible Person” for the brand “Cephalex 500”:              NJ        substitute:         CR

    (b)omit:

Pharmacor Cephalexin 500 CR PDP 20 0 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]

    (a)omit from the column headed “Responsible Person” for the brand “Cephalex 500”:              NJ        substitute:         CR

    (b)omit:

Pharmacor Cephalexin 500 CR MP NP MW 20 1 20

  1. Schedule 1, entry for Cetrorelix

    substitute:

Cetrorelix Powder for injection 250 micrograms (as acetate) with diluent Injection Cetrotide SG MP

 C5046 10 0 10 D(100)

  1. Schedule 1, entry for Choriogonadotropin alfa

    substitute:

Choriogonadotropin alfa Solution for injection 250 micrograms in 0.5 mL pre-filled syringe Injection Ovidrel SG MP

 C5019 10 0 1 D(100)
Solution for injection 250 micrograms in 0.5 mL pre-filled pen Injection Ovidrel SG MP

 C5019 10 0 1 D(100)

  1. Schedule 1, entry for Chorionic Gonadotrophin

    substitute:

Chorionic Gonadotrophin Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL Injection Pregnyl MK MP C5027 1 0 1 C(100)
C1116 C1117 C1118 C1120 C1878 1

 5 1
Powder for injection 5,000 units with solvent Injection Pregnyl MK MP

 C5027 2 0 1 PB(100)

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

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

APO-Ciprofloxacin TX MP NP C1143 C1431 C1432 C1572 C1573 14 0 14

  1. Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)

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

APO-Ciprofloxacin TX MP NP C1431 C1432 C1572 C1573 14 0 14

  1. Schedule 1, entry for Clozapine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; Tablet 200 mg; and Oral liquid 50 mg
    per mL, 100 mL

    omit from the column headed “Circumstances”:       C4371  C4411    substitute:             C4998  C5001  C5015

  2. Schedule 1, entry for Corifollitropin Alfa

    substitute:

Corifollitropin alfa Solution for injection 100 micrograms in 0.5 mL single dose pre-filled syringe Injection Elonva MK MP

 C5009 1 0 1 D(100)
Solution for injection 150 micrograms in 0.5 mL single dose pre-filled syringe Injection Elonva MK MP

 C5009 1 0 1 D(100)

  1. Schedule 1, after entry for Cortisone in the form Tablet containing cortisone acetate 25 mg

    insert:

Crizotinib Capsule 200 mg Oral Xalkori PF MP C5047 C5048 C5049 60 1 60
Capsule 250 mg Oral Xalkori PF MP C5047 C5048 C5049 60 1 60

  1. Schedule 1, entry for Dabrafenib in each of the forms: Capsule 50 mg (as mesilate); and Capsule 75 mg (as mesilate)

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

  2. Schedule 1, entry for Dapagliflozin

    omit from the column headed “Circumstances”:       C4825  C4844    substitute:             C4983  C4991  C5062

  3. Schedule 1, entry for Darunavir in each of the forms: Tablet 150 mg (as ethanolate); and Tablet 600 mg (as ethanolate)

    omit from the column headed “Circumstances”:       C3594  C3595    substitute:             C4313 

  4. Schedule 1, entry for Darunavir in the form Tablet 800 mg (as ethanolate)

    omit from the column headed “Circumstances”:       C4346  

  5. Schedule 1, entry for Didanosine in each of the forms: Capsule 125 mg (containing enteric coated beadlets); Capsule 200 mg (containing enteric coated beadlets); Capsule 250 mg (containing enteric coated beadlets); and Capsule 400 mg (containing enteric coated beadlets)

    omit from the column headed “Circumstances”:       C4455  C4469

  6. Schedule 1, entry for Dolutegravir

    omit from the column headed “Circumstances”:       C4455  C4469

  7. Schedule 1, entry for Dolutegravir with abacavir and lamivudine

    (a)omit from the column headed “Circumstances”:           C4472

    (b)omit from the column headed “Circumstances”:           C4523

  8. Schedule 1, entry for Dorzolamide with timolol

    omit from the column headed “Circumstances” for the brand “Cosdor” [Authorised Prescriber AO]:          C4326    substitute:                C5038

  9. Schedule 1, entry for Dorzolamide with timolol

    omit from the column headed “Circumstances” for the brand “Cosopt” [Authorised Prescriber AO]:           C4326    substitute:                C5038

  10. Schedule 1, entry for Dorzolamide with timolol

    omit from the column headed “Circumstances” for the brand “Dorzolamide/Timolol Sandoz 20/5” [Authorised Prescriber AO]:                 C4326   
    substitute:                 C5038

  11. Schedule 1, entry for Efavirenz in each of the forms: Tablet 200 mg; Tablet 600 mg; and Oral solution 30 mg per mL, 180 mL

    omit from the column headed “Circumstances”:       C4455  C4469

  12. Schedule 1, entry for Eltrombopag in each of the forms: Tablet 25 mg (as olamine); and Tablet 50 mg (as olamine)

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

  13. Schedule 1, entry for Emtricitabine

    omit from the column headed “Circumstances”:       C4455  C4469

  14. Schedule 1, entry for Enfuvirtide

    omit from the column headed “Circumstances”:       C3596  C3597    substitute:             C5014 

  1. Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]

    omit from the column headed “Purposes”:   P1148   substitute:             P4910

  2. Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]

    omit from the column headed “Purposes”:   P1148   substitute:             P4910

  3. Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]

    omit from the column headed “Purposes”:   P1148   substitute:             P4910

  4. Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]

    omit from the column headed “Purposes”:   P1148   substitute:             P4910

  5. Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]

    omit from the column headed “Purposes”:   P1148   substitute:             P4910

  6. Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 0.5 mg

    omit from the column headed “Circumstances”:       C3959  C3960  C3961  C3962     substitute:             C4993  C5036

  7. Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg

    omit from the column headed “Circumstances”:       C3963  C3964  C3965  C3966     substitute:             C5037  C5044 

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

    omit from the column headed “Responsible Person” for the brand “Esipram”:   UA          substitute:             CF

  9. Schedule 1, entry for Esomeprazole

    substitute:

Esomeprazole Capsule (enteric) 20 mg (as magnesium) Oral Noxicid Caps AL MP NP C4988 C5029 C5030 C5039 P4988 30 1 30
MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30
Capsule (enteric) 40 mg (as magnesium) Oral Noxicid Caps AL MP NP C5011 C5021 C5028 P5028 30 1 30
MP NP C5011 C5021 C5028 P5011 P5021 30 5 30
Tablet (enteric coated) 20 mg (as magnesium trihydrate) Oral Esomeprazole AN EA MP NP C4988 C5029 C5030 C5039 P4988 30 1 30
Esomeprazole Apotex TX MP NP C4988 C5029 C5030 C5039 P4988 30 1 30
Esomeprazole GxP AF MP NP C4988 C5029 C5030 C5039 P4988 30 1 30
Esomeprazole RBX RA MP NP C4988 C5029 C5030 C5039 P4988 30 1 30
Esomeprazole Sandoz SZ MP NP C4988 C5029 C5030 C5039 P4988 30 1 30
Nexium AP MP NP C4988 C5029 C5030 C5039 P4988 30 1 30
Nexole QA MP NP C4988 C5029 C5030 C5039 P4988 30 1 30
Esomeprazole AN EA MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30
Esomeprazole Apotex TX MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30
Esomeprazole GxP AF MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30
Esomeprazole RBX RA MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30
Esomeprazole Sandoz SZ MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30
Nexium AP MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30
Nexole QA MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30
Tablet (enteric coated) 40 mg (as magnesium trihydrate) Oral Esomeprazole AN EA MP NP C5011 C5021 C5028 P5028 30 1 30
Esomeprazole Apotex TX MP NP C5011 C5021 C5028 P5028 30 1 30
Esomeprazole GxP AF MP NP C5011 C5021 C5028 P5028 30 1 30
Esomeprazole RBX RA MP NP C5011 C5021 C5028 P5028 30 1 30
Esomeprazole Sandoz SZ MP NP C5011 C5021 C5028 P5028 30 1 30
Nexium AP MP NP C5011 C5021 C5028 P5028 30 1 30
Nexole QA MP NP C5011 C5021 C5028 P5028 30 1 30
Esomeprazole AN EA MP NP C5011 C5021 C5028 P5011 P5021 30 5 30
Esomeprazole Apotex TX MP NP C5011 C5021 C5028 P5011 P5021 30 5 30
Esomeprazole GxP AF MP NP C5011 C5021 C5028 P5011 P5021 30 5 30
Esomeprazole RBX RA MP NP C5011 C5021 C5028 P5011 P5021 30 5 30
Esomeprazole Sandoz SZ MP NP C5011 C5021 C5028 P5011 P5021 30 5 30
Nexium AP MP NP C5011 C5021 C5028 P5011 P5021 30 5 30
Nexole QA MP NP C5011 C5021 C5028 P5011 P5021 30 5 30

  1. Schedule 1, entry for Etravirine

    omit from the column headed “Circumstances”:       C3596  C3597    substitute:             C5014

  2. Schedule 1, entry for Follitropin Alfa

    substitute:

Follitropin Alfa Injection 300 I.U. in 0.5 mL multi‑dose cartridge Injection Gonal‑f Pen SG MP

 C1119 C1878

 3 5 1
MP C5027 2 0 1 C(100)
Injection 450 I.U. in 0.75 mL multi-dose cartridge Injection Gonal‑f Pen SG MP

 C1119 C1878

 3 5 1
MP C5027 2 0 1 C(100)
Injection 900 I.U. in 1.5 mL multi-dose cartridge Injection Gonal‑f Pen SG MP

 C1119 C1878

 2 5 1
MP C5027 5 0 1 C(100)

  1. Schedule 1, entry for Follitropin Beta

    substitute:

Follitropin Beta Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge Injection Puregon 300 IU/0.36 mL MK MP

 C1119 C1878

 3 5 1
MP C5027 2 0 1 C(100)
Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge Injection Puregon 600 IU/0.72 mL MK MP

 C1119 C1878

 2 5 1
MP C5027 4 0 1 C(100)
Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge Injection Puregon 900 IU/1.08 mL MK MP

 C1119 C1878

 2 5 1
MP C5027 5 0 1 C(100)

  1. Schedule 1, entry for Fosamprenavir in each of the forms: Tablet 700 mg (as calcium); and Oral liquid 50 mg (as calcium) per mL, 225 mL

    omit from the column headed “Circumstances”:       C4455  C4469

  2. Schedule 1, entry for Foscarnet

    omit from the column headed “Circumstances”:       C1413  C1610  C3322  C3378     substitute:             C4973  C4980 

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

    omit from the column headed “Responsible Person” for the brand “Gabacor”:  NJ           substitute:             CR

  4. Schedule 1, entry for Gabapentin in the form Capsule 300 mg

    (a)omit from the column headed “Responsible Person” for the brand “Gabacor”:     NJ       substitute:         CR

    (b)omit:

Gabapentin 300 CR MP NP C2664 100 5 100

  1. Schedule 1, entry for Gabapentin in the form Capsule 400 mg

    (a)omit from the column headed “Responsible Person” for the brand “Gabacor”:     NJ       substitute:         CR

    (b)omit:

Gabapentin 400 CR MP NP C2664 100 5 100

  1. Schedule 1, entry for Ganciclovir

    omit from the column headed “Circumstances”:       C1612  C1830  C1831  C3379  C3380  C3381      
    substitute:             C4972  C4990  C4999  C5000  C5025

  2. Schedule 1, entry for Ganirelix

    substitute:

Ganirelix Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe Injection Orgalutran MK MP C5046 10 0 1 D(100)
MP C5046 10 0 5 D(100)

  1. Schedule 1, entry for Glucose Indicator—Blood

    omit:

Test strips, 100 (Accu‑Chek Advantage/Sensor Comfort) For external use Accu‑Chek Advantage/
Sensor Comfort 		RD MP NP 1 5 1
MP P4241 1 11 1

  1. Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Bars 81 g, 7 (Camino Pro Complete)

    insert in the columns in the order indicated:

Oral liquid 250 mL, 30 (PKU Glytactin RTD 10) Oral PKU Glytactin RTD 10 QH MP NP C5012 4 5 1
Oral liquid 250 mL, 30 (PKU Glytactin RTD 15) Oral PKU Glytactin RTD 15 QH MP NP C5012 4 5 1

  1. Schedule 1, entry for Human menopausal gonadotrophin

    substitute:

Human menopausal gonadotrophin Powder for injection 600 I.U. with solvent Injection Menopur 600 FP MP

 C5027 3 0 1 D(100)
Powder for injection 1,200 I.U. with solvent Injection Menopur 1200 FP MP

 C5027 4 0 1 D(100)

  1. Schedule 1, entry for Hydroxychloroquine

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

Hequinel QA MP NP 100 1 100

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

Hydroxychloroquine AN EA MP NP 100 1 100

  1. Schedule 1, entry for Indinavir

    omit from the column headed “Circumstances”:       C4455  C4469

  2. Schedule 1, entry for Insect Allergen Extract—Honey Bee Venom

    omit from the column headed “Responsible Person”:                 HL          substitute:             DE

  3. Schedule 1, entry for Insect Allergen Extract—Paper Wasp Venom

    omit from the column headed “Responsible Person”:                 HL          substitute:             DE

  4. Schedule 1, entry for Insect Allergen Extract—Yellow Jacket Venom

    omit from the column headed “Responsible Person”:                 HL          substitute:             DE

  5. Schedule 1, entry for Interferon Alfa-2a in the form Injection 3,000,000 I.U. in 0.5 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]

    omit from the column headed “Circumstances”:       C1463  C3382  C3959  C3960  C3961  C3962       substitute:                C4993  C5003  C5036  C5042

  6. Schedule 1, entry for Interferon Alfa-2a in the form Injection 4,500,000 I.U. in 0.5 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]

    omit from the column headed “Circumstances”:       C1463  C3382  C3959  C3960  C3961  C3962       substitute:                C4993  C5003  C5036  C5042

  7. Schedule 1, entry for Interferon Alfa-2a in the form Injection 6,000,000 I.U. in 0.5 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]

    omit from the column headed “Circumstances”:       C1463  C3382  C3959  C3960  C3961  C3962       substitute:                C4993  C5003  C5036  C5042

  8. Schedule 1, entry for Interferon Alfa-2a in the form Injection 9000,000 I.U. in 0.5 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]

    omit from the column headed “Circumstances”:       C1463  C3382  C3959  C3960  C3961  C3962       substitute:                C4993  C5003  C5036  C5042

  1. Schedule 1, entry for Interferon Alfa-2b

    substitute:

Interferon Alfa‑2b Solution for injection 10,000,000 I.U. in 1 mL single dose vial Injection Intron A MK MP

 C4974 C4993 C5003 C5033 C5036 C5042 15 5 5 PB(100)
Solution for injection 18,000,000 I.U. in 1.2 mL multi‑dose injection pen Injection Intron A Redipen MK MP

 C4974 C4993 C5003 C5033 C5036 C5042 2 5 1 C(100)
MP

 C1149 C1196 C1206 C3180 C3895 C3898 P1149 P3180 3 4 1
MP

 C1149 C1196 C1206 C3180 C3895 C3898 P1196 P1206 P3895 P3898 3 5 1
Solution for injection 18,000,000 I.U. in 3 mL single dose vial Injection Intron A MK MP

 C4974 C4993 C5003 C5033 C5036 C5042 15 5 1 PB(100)
Solution for injection 25,000,000 I.U. in 2.5 mL single dose vial Injection Intron A MK MP

 C4974 C4993 C5003 C5033 C5036 C5042 15 5 1 PB(100)
Solution for injection 30,000,000 I.U. in 1.2 mL multi‑dose injection pen Injection Intron A Redipen MK MP

 C4974 C4993 C5003 C5033 C5036 C5042 2 5 1 C(100)
MP

 C1196 C1206 C3895 C3898 3 5 1
Solution for injection 60,000,000 I.U. in 1.2 mL multi‑dose injection pen Injection Intron A Redipen MK MP

 C4974 C4993 C5003 C5033 C5036 C5042 2 5 1 PB(100)

  1. Schedule 1, entry for Ivabradine in each of the forms: Tablet 5 mg (as hydrochloride); and Tablet 7.5 mg (as hydrochloride)

    omit from the column headed “Circumstances”:       C4310   substitute:             C4979

  2. Schedule 1, entry for Lacosamide

    omit:

Tablet 50 mg Oral Vimpat UC MP NP C4271 14 1 14

substitute:

Tablet 50 mg Oral Vimpat UC MP NP C4249 C4271 P4271 14 1 14
MP NP C4249 C4271 P4249 56 5 14

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

    omit from the column headed “Circumstances” (twice occurring):      C3959  C3960  C3961  C3962     substitute:                C4993  C5036

  2. Schedule 1, entry for Lamivudine in each of the forms: Tablet 150 mg; and Tablet 300 mg

    omit from the column headed “Circumstances” (all instances):           C4455  C4469

  3. Schedule 1, entry for Lamivudine in the form Oral solution 5 mg per mL, 240 mL

    omit from the column headed “Circumstances”:       C3959  C3960  C3961  C3962     substitute:             C4993  C5036

  4. Schedule 1, entry for Lamivudine in the form Oral solution 10 mg per mL, 240 mL

    omit from the column headed “Circumstances”:       C4455  C4469

  5. Schedule 1, entry for Lamivudine with Zidovudine

    omit from the column headed “Circumstances” (twice occurring):      C4455  C4469

  6. Schedule 1, entry for Lapatinib

    (a)omit from the column headed “Responsible Person”:     GK       substitute:         NV

    (b)omit from the column headed “Circumstances”:           C2890  C3433    substitute:         C4985  C5040

  7. Schedule 1, entry for Latanoprost with timolol

    omit from the column headed “Circumstances” for the brand “APO-Latanoprost/Timolol 0.05/5” [Authorised Prescriber AO]:                C4326
    substitute:                 C5038

  8. Schedule 1, entry for Latanoprost with timolol

    omit from the column headed “Circumstances” for the brand “Latanocom” [Authorised Prescriber AO]:   C4326    substitute:                C5038

  9. Schedule 1, entry for Latanoprost with timolol

    omit from the column headed “Circumstances” for the brand “Latanoprost/Timolol Sandoz 50/5” [Authorised Prescriber AO]:                 C4326
    substitute:                 C5038

  10. Schedule 1, entry for Latanoprost with timolol

    omit from the column headed “Circumstances” for the brand “Xalacom” [Authorised Prescriber AO]:        C4326    substitute:                C5038

  11. Schedule 1, entry for Latanoprost with timolol

    omit from the column headed “Circumstances” for the brand “Xalamol 50/5” [Authorised Prescriber AO]:               C4326                substitute:             C5038

  12. Schedule 1, entry for Lopinavir with Ritonavir in each of the forms: Tablet 100 mg-25 mg; Tablet 200 mg-50 mg; and Oral liquid
    400 mg-100 mg per 5 mL, 60 mL

    omit from the column headed “Circumstances”:       C4455  C4469

  13. Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 1; Number of Repeats: 5]

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

Chemists’ Own Macrogol with Electrolytes FM MP NP

 C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2 		P4576 P4577 P4580 P4596 P4601
See Note 2 		1
See Note 2 		5
See
Note 2 		1

  1. Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 2; Number of Repeats: 0]

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

Chemists’ Own Macrogol with Electrolytes FM MP NP

 C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2 		P4590
See Note 2 		2
See Note 2 		0
See
Note 2 		1

  1. Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 2; Number of Repeats: 3]

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

Chemists’ Own Macrogol with Electrolytes FM MP NP

 C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2 		P4595
See Note 2 		2
See Note 2 		3
See
Note 2 		1

  1. Schedule 1, entry for Maraviroc in each of the forms: Tablet 150 mg; and Tablet 300 mg

    omit from the column headed “Circumstances”:       C3598  C3599    substitute:             C5008

  2. Schedule 1, entry for Meloxicam in each of the forms: Capsule 7.5 mg; and Capsule 15 mg

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

Meloxicam Sandoz SZ MP NP C1547 C1848 30 3 30

  1. Schedule 1, entry for Nafarelin

    substitute:

Nafarelin Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses Nasal Synarel PF MP C1172 C1389

 1 5 1
MP C5046 2 0 1 C(100)

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

    omit from the column headed “Circumstances”:       C4455  C4469

  2. Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)

    omit from the column headed “Circumstances”:       C4460  C4469

  3. Schedule 1, entry for Nevirapine in the form Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL

    omit from the column headed “Circumstances”:       C4455  C4469

  1. Schedule 1, entry for Norfloxacin

    omit:

Norfloxacin AN EA MP NP C1002 C1070 14 1 14

  1. Schedule 1, entry for Ofatumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 1000 mg in 50 mL

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

  2. Schedule 1, entry for Pazopanib in each of the forms: Tablet 200 mg (as hydrochloride); and Tablet 400 mg (as hydrochloride)

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

  3. Schedule 1, entry for Peginterferon Alfa-2a in each of the forms: Injection 135 micrograms in 0.5 mL single use pre-filled syringe; and Injection 180 micrograms in 0.5 mL single use pre-filled syringe

    omit from the column headed “Circumstances”:       C2334  C3412C3975  C3976  C3977  C3978       substitute:            C5004  C5010  C5016  C5067

  4. Schedule 1, after entry for Permethrin

    insert:

Pertuzumab Solution for I.V. infusion 420 mg in 14 mL Injection Perjeta RO MP C4971 C5013 C5023 See Note 3 See Note 3 1 D(100)
MP C4971 C5013 C5023 See Note 3 See Note 3 1 D(100)
MP C4971 C5013 C5023 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Progesterone

    substitute:

Progesterone Vaginal gel (prolonged release) 90 mg in single dose pre-filled applicator Vaginal Crinone 8% SG MP

C5045

 30 0 15 D(100)
Vaginal tablet 100 mg Vaginal Endometrin FP MP C4997 42 0 21 D(100)
Pessary 100 mg Vaginal Oripro ON MP C4997 45 0 15 D(100)
Pessary 200 mg Vaginal Oripro ON MP C4997 45 0 15 D(100)

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)

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

Parbezol QA MP NP C1337 C1533 28 5 28

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]

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

Parbezol QA MP NP C1177 C1337 C1533 P1177 30 2 30

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]

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

Parbezol QA MP NP C1177 C1337 C1533 P1337 P1533 30 5 30

  1. Schedule 1, entry for Raltegravir in each of the forms: Tablet 25 mg (as potassium); and Tablet 100 mg (as potassium)

    (a)omit from the column headed “Circumstances”:           C4273

    (b)omit from the column headed “Circumstances”:           C4276

  2. Schedule 1, entry for Raltegravir in the form Tablet 400 mg (as potassium)

    omit from the column headed “Circumstances”:       C4455  C4469

  3. Schedule 1, entry for Ranibizumab

    substitute:

Ranibizumab Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe Injection Lucentis NV MP C4803 C4804 C5050 C5051 C5052 C5053 C5054 C5055 P4803 P4804 P5050 P5051 P5053 P5054 1 2 1
C4803 C4804 C5050 C5051 C5052 C5053 C5054 C5055 P5052 P5055 1 5 1
Solution for intravitreal injection 2.3 mg in 0.23 mL Injection Lucentis NV MP C4803 C4804 C5050 C5051 C5052 C5053 C5054 C5055 P4803 P4804 P5050 P5051 P5053 P5054 1 2 1
C4803 C4804 C5050 C5051 C5052 C5053 C5054 C5055 P5052 P5055 1 5 1

  1. Schedule 1, entry for Rilpivirine

    omit from the column headed “Circumstances”:       C4455  C4469

  2. Schedule 1, entry for Ritonavir in each of the forms: Tablet 100 mg; and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL

    omit from the column headed “Circumstances”:       C4455  C4469

  3. Schedule 1, entry for Saquinavir

    omit from the column headed “Circumstances”:       C4455  C4469

  4. Schedule 1, entry for Stavudine in each of the forms: Capsule 20 mg; Capsule 30 mg; and Capsule 40 mg

    omit from the column headed “Circumstances”:       C4455  C4469

  5. Schedule 1, entry for Telbivudine

    omit from the column headed “Circumstances”:       C3967  C3968  C3969  C3970     substitute:          C4994  C4995 

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

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

APO-Temozolomide TX MP 5 5 5

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

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

APO-Temozolomide TX MP P4897 15
CN4897 		2
CN4897 		5

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

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

APO-Temozolomide TX MP 5 5 5

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

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

APO-Temozolomide TX MP P4897 15
CN4897 		2
CN4897 		5

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

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

APO-Temozolomide TX MP 5 5 5

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

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

APO-Temozolomide TX MP P4897 15
CN4897 		2
CN4897 		5

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

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

APO-Temozolomide TX MP 5 5 5

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

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

APO-Temozolomide TX MP P4897 15
CN4897 		2
CN4897 		5

  1. Schedule 1, entry for Temozolomide in the form Capsule 180 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

APO-Temozolomide TX MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 180 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

APO-Temozolomide TX MP P4897 15
CN4897 		2
CN4897 		5

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

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

APO-Temozolomide TX MP 5 5 5

  1. Schedule 1, entry for Tenofovir

    (a)omit from the column headed “Circumstances”:           C4455  C4469

    (b)omit from the column headed “Circumstances”:           C4499  C4509

    (c)omit from the column headed “Circumstances”:           C4544  C4545

  2. Schedule 1, entry for Tenofovir with Emtricitabine

    omit from the column headed “Circumstances”:       C4455  C4469

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

    (a)omit from the column headed “Circumstances”:           C4494 

    (b)omit from the column headed “Circumstances”:           C4533  

  4. Schedule 1, entry for Tenofovir with Emtricitabine and Rilpivirine

    (a)omit from the column headed “Circumstances”:           C4494 

    (b)omit from the column headed “Circumstances”:           C4533  

  5. Schedule 1, entry for Tenofovir with emtricitabine, elvitegravir and cobicistat

    (a)omit from the column headed “Circumstances”:           C4494 

    (b)omit from the column headed “Circumstances”:           C4533  

  6. Schedule 1, entry for Tipranavir

    omit from the column headed “Circumstances”:       C3600  C3601    substitute:             C4981 

  7. Schedule 1, entry for Topotecan

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

  8. Schedule 1, entry for Trastuzumab

    substitute:

Trastuzumab Powder for I.V. infusion 60 mg Injection Herceptin RO MP C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164 C5024 C5032 C5041 See Note 3 See Note 3 1 D(100)
Powder for I.V. infusion 150 mg Injection Herceptin RO MP C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164 C5024 C5032 C5041 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, after entry for Trastuzumab

    insert:

Trastuzumab emtansine Powder for I.V. infusion 100 mg Injection Kadcyla RO MP C4978 C4986 C4987 See Note 3 See Note 3 1 D(100)
Powder for I.V. infusion 160 mg Injection Kadcyla RO MP C4978 C4986 C4987 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Travoprost with timolol

    omit from the column headed “Circumstances” [Authorised Prescriber AO]:      C4326    substitute:             C5038

  2. Schedule 1, entry for Valganciclovir in each of the forms: Tablet 450 mg (as hydrochloride); and Powder for oral solution 50 mg
    (as hydrochloride) per mL, 100 mL

    omit from the column headed “Circumstances”:       C1620  C1964  C3420  C3421     substitute:             C4980  C4989  C5031

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

    omit:

Dilart HCT 160/12.5 AF MP NP C4374 28 5 28

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

    omit:

Dilart HCT 160/25 AF MP NP C4374 28 5 28

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

    omit:

Dilart HCT 320/12.5 AF MP NP C4361 28 5 28

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

    omit:

Dilart HCT 320/25 AF MP NP C4361 28 5 28

  1. Schedule 1, entry for Zidovudine in each of the forms: Capsule 100 mg; Capsule 250 mg; and Syrup 10 mg per mL, 200 mL

    omit from the column headed “Circumstances”:       C4455  C4469

  2. Schedule 3, after details relevant to Responsible Person code BZ

    insert:

CF CNS Pharma Pty Ltd  76 121 515 400

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

    insert:

DE Stallergenes Australia Pty Ltd  17 151 366 540

  1. Schedule 3

    omit:

HL Helex-A Pty. Ltd.  89 070 826 176

  1. Schedule 3

    omit:

NJ Norac Pharma Australia Pty Ltd  22 164 670 008

  1. Schedule 4, Part 1, entry for Abacavir

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

(b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Abacavir with Lamivudine

    (a)omit:

C4505

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

 Compliance with Written or Telephone Authority Required procedures

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4527 and C4528:   

Where the patient is receiving treatment at/from a public hospital

(c)omit:

C4538

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Abacavir with Lamivudine and Zidovudine

    (a)omit:

C4472

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

 Compliance with Written or Telephone Authority Required procedures

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4480 and C4495:   

Where the patient is receiving treatment at/from a public hospital

(c)omit:

C4523

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Adefovir

    substitute:

Adefovir C4490

Chronic hepatitis B infection

Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4490
C4510

Chronic hepatitis B infection

Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA

Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4510

  1. Schedule 4, Part 1, entry for Atazanavir

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Bimatoprost with timolol

    (a)omit:

C4326

Elevated intra‑ocular pressure

The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension

(b)insert in numerical order after existing text:

C5038

Elevated intra-ocular pressure

The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension

  1. Schedule 4, Part 1, entry for Brimonidine with timolol

    (a)omit:

C4326

Elevated intra‑ocular pressure

The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension

(b)insert in numerical order after existing text:

C5038

Elevated intra-ocular pressure

The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension

  1. Schedule 4, Part 1, entry for Brinzolamide with timolol

    (a)omit:

C4326

Elevated intra‑ocular pressure

The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension

(b)insert in numerical order after existing text:

C5038

Elevated intra-ocular pressure

The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension

  1. Schedule 4, Part 1, entry for Captopril

    substitute:

Captopril C4996 Patients unable to take a solid dose form of an ACE inhibitor

  1. Schedule 4, Part 1, after entry for Certolizumab pegol

    insert:

Cetrorelix C5046

Assisted Reproductive Technology

The treatment must be for prevention of premature luteinisation and ovulation; AND
Patient must be undergoing controlled ovarian stimulation; AND
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule

 Compliance with Authority Required procedures - Streamlined Authority Code 5046

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

    insert:

Choriogonadotropin alfa C5019

Assisted Reproductive Technology

Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule

 Compliance with Authority Required procedures - Streamlined Authority Code 5019

  1. Schedule 4, Part 1, entry for Chorionic Gonadotrophin

    insert in numerical order:

C5027

Assisted Reproductive Technology

Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule

 Compliance with Authority Required procedures - Streamlined Authority Code 5027

  1. Schedule 4, Part 1, entry for Clozapine

    substitute:

Clozapine C4998

Schizophrenia

Continuing treatment

Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND
Patient must have completed at least 18 weeks therapy; AND
Patient must be on a clozapine dosage considered stable by a treating psychiatrist; AND
The treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals

Must be treated by a psychiatrist; OR
Must be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist

A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised

 Compliance with Authority Required procedures - Streamlined Authority Code 4998
C5001

Schizophrenia

Initial treatment

Patient must be non-responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents

Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient

Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction

The name of the consulting psychiatrist should be included in the patient's medical records

A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised

 Compliance with Written or Telephone Authority Required procedures
C5015

Schizophrenia

Initial treatment

Patient must be non-responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents

Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient

Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction

The name of the consulting psychiatrist should be included in the patient's medical records

A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorisedt

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5015

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

    insert:

Corifollitropin alfa C5009

Assisted Reproductive Technology

The treatment must be for controlled ovarian stimulation; AND
Patient must have an antral follicle count of 20 or less; AND
Patient must be receiving medical services as described in items 13200, 13201, or 13202 of the Medicare Benefits Schedule; AND
Patient must be undergoing a gonadotrophin releasing antagonist cycle

 Compliance with Authority Required procedures - Streamlined Authority Code 5009

  1. Schedule 4, Part 1, after entry for Corifollitropin alfa

    insert:

Crizotinib C5047

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Grandfathering treatment

Patient must have received treatment with crizotinib for this condition prior to 1 July 2015; AND
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not have progressive disease

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ALK-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ALK gene rearrangement in tumour material by FISH testing

 Compliance with Written Authority Required procedures
C5048

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment

The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease

 Compliance with Written or Telephone Authority Required procedures
C5049

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ALK-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ALK gene rearrangement in tumour material by FISH testing

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Dapagliflozin

    substitute:

Dapagliflozin C4983

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea

The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated

The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated

Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months

The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records

A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug

 Compliance with Authority Required procedures - Streamlined Authority Code 4983
C4991

Diabetes mellitus type 2

The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated

The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated

The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated

Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months

The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records

 Compliance with Authority Required procedures - Streamlined Authority Code 4991
C5062

Diabetes mellitus type 2

The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea

The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated

The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated

Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months

The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records

 Compliance with Authority Required procedures - Streamlined Authority Code 5062

  1. Schedule 4, Part 1, entry for Darunavir

    (a)omit:

C3594

Where the patient is receiving treatment at/from a private hospital

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity

 Compliance with Written or Telephone Authority Required procedures
C3595

Where the patient is receiving treatment at/from a public hospital

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3595

(b)omit:

C4346

Human immunodeficiency virus (HIV) infection

The treatment must be in addition to optimised background therapy;
The treatment must be in combination with other antiretroviral agents;
The treatment must be co‑administered with 100 mg ritonavir;

Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen;
Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity

 Compliance with Written and Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Didanosine

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Dolutegravir

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Dolutegravir with abacavir and lamivudine

    (a)omit:

C4472

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

 Compliance with Written or Telephone Authority Required procedures

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4480 and C4495:    

Where the patient is receiving treatment at/from a public hospital

(c)omit:

C4523

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Dorzolamide with timolol

    (a)omit:

C4326

Elevated intra‑ocular pressure

The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension

(b)insert in numerical order after existing text:

C5038

Elevated intra-ocular pressure

The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension

  1. Schedule 4, Part 1, entry for Efavirenz

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Emtricitabine

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Enfuvirtide

    substitute:

Enfuvirtide C5014

HIV infection

The treatment must be in addition to optimised background therapy; AND
The treatment must be in combination with other antiretroviral agents; AND
Patient must be antiretroviral experienced; AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5014

  1. Schedule 4, Part 1, entry for Enoxaparin

    omit:

P1148 Haemodialysis

  1. Schedule 4, Part 1, entry for Entecavir

    substitute:

Entecavir C4993

Chronic hepatitis B infection

Patient must not have cirrhosis; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4993
C5036

Chronic hepatitis B infection

Patient must have cirrhosis; AND
Patient must have detectable HBV DNA

Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5036
C5037

Chronic hepatitis B infection

Patient must have cirrhosis; AND
Patient must have failed lamivudine; AND
Patient must have detectable HBV DNA

Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5037
C5044

Chronic hepatitis B infection

Patient must not have cirrhosis; AND
Patient must have failed lamivudine; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5044

  1. Schedule 4, Part 1, entry for Esomeprazole

    substitute:

Esomeprazole C4988 P4988

Gastric ulcer

Initial treatment
C5011 P5011 Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion Compliance with Authority Required procedures
C5021 P5021 Scleroderma oesophagus Compliance with Authority Required procedures
C5028 P5028

Gastro-oesophageal reflux disease

The treatment must be for the healing of gastro-oesophageal reflux disease
C5029 P5029

Gastro-oesophageal reflux disease

The treatment must be maintenance therapy; AND
The condition must be healed
C5030 P5030 Scleroderma oesophagus
C5039 P5039 Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion

  1. Schedule 4, Part 1, entry for Etravirine

    substitute:

Etravirine C5014

HIV infection

The treatment must be in addition to optimised background therapy; AND
The treatment must be in combination with other antiretroviral agents; AND
Patient must be antiretroviral experienced; AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5014

  1. Schedule 4, Part 1, entry for Follitropin Alfa

    insert in numerical order:

C5027

Assisted Reproductive Technology

Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule

 Compliance with Authority Required procedures - Streamlined Authority Code 5027

  1. Schedule 4, Part 1, entry for Follitropin Beta

    insert in numerical order:

C5027

Assisted Reproductive Technology

Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule

 Compliance with Authority Required procedures - Streamlined Authority Code 5027

  1. Schedule 4, Part 1, entry for Fosamprenavir

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Foscarnet

    substitute:

Foscarnet C4973

Herpes simplex virus infection

The condition must be aciclovir resistant; AND
Patient must have HIV infection

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4973
C4980

Cytomegalovirus retinitis

Patient must have HIV infection

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4980

  1. Schedule 4, Part 1, entry for Ganciclovir

    substitute:

Ganciclovir C4972

Cytomegalovirus disease

Prophylaxis

Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4972
C4990

Cytomegalovirus disease

Prophylaxis

Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease

 Compliance with Written or Telephone Authority Required procedures
C4999

Cytomegalovirus disease

Prophylaxis

Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4999
C5000

Cytomegalovirus retinitis

Patient must be severely immunocompromised, inculding due to HIV infection

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5000
C5025

Cytomegalovirus disease

Prophylaxis

Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease

 Compliance with Written or Telephone Authority Required procedures

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

    insert:

Ganirelix C5046

Assisted Reproductive Technology

The treatment must be for prevention of premature luteinisation and ovulation; AND
Patient must be undergoing controlled ovarian stimulation; AND
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule

 Compliance with Authority Required procedures - Streamlined Authority Code 5046

  1. Schedule 4, Part 1, entry for Glycomacropeptide and essential amino acids with vitamins and minerals

    insert in numerical order:

C5012 Phenylketonuria

  1. Schedule 4, Part 1, after entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

    insert:

Human menopausal gonadotrophin C5027

Assisted Reproductive Technology

Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule

 Compliance with Authority Required procedures - Streamlined Authority Code 5027

  1. Schedule 4, Part 1, entry for Indinavir

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Interferon Alfa-2a

    (a)omit:

C1463

Where the patient is receiving treatment at/from a private hospital

Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase

 Compliance with Written or Telephone Authority Required procedures

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Code C3180:           

Where the patient is receiving treatment at/from a public hospital

(c)omit:

C3382

Where the patient is receiving treatment at/from a public hospital

Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3382

(d)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C3895 and C3899:    

Where the patient is receiving treatment at/from a public hospital

(e)      omit:

C3959

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA

Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

 Compliance with Written or Telephone Authority Required procedures
C3960

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels ‑ greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative ‑ in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy

 Compliance with Written or Telephone Authority Required procedures
C3961

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels ‑ greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative ‑ in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3961
C3962

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.

Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3962

  1. Schedule 4, Part 1, entry for Rilpivirine

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Ritonavir

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Saquinavir

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Stavudine

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Telbivudine

    substitute:

Telbivudine C4994

Chronic hepatitis B infection

Patient must have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition

Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4994
C4995

Chronic hepatitis B infection

Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4995

  1. Schedule 4, Part 1, entry for Tenofovir

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4476, C4489 and C4490:     

Where the patient is receiving treatment at/from a public hospital

(d)omit:

C4499

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B

Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition

 Compliance with Written or Telephone Authority Required procedures
C4509

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B

Patient must have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition

Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

 Compliance with Written or Telephone Authority Required procedures

(e)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4510 and C4512:    

Where the patient is receiving treatment at/from a public hospital

(f)omit:

C4544

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B

Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance

 Compliance with Written or Telephone Authority Required procedures
C4545

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B

Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA

Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Tenofovir with Emtricitabine

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

  1. Schedule 4, Part 1, entry for Tenofovir with emtricitabine and efavirenz

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4470:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4494

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

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

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4522:           

Where the patient is receiving treatment at/from a public hospital

(d)omit:

C4533

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naive

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Tenofovir with Emtricitabine and Rilpivirine

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4470:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4494

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

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

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4522:           

Where the patient is receiving treatment at/from a public hospital

(d)omit:

C4533

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naive

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Tenofovir with emtricitabine, and elvitegravir and cobicistat

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4470:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4494

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

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

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4522:           

Where the patient is receiving treatment at/from a public hospital

(d)omit:

C4533

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naive

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Tipranavir

    substitute:

Tipranavir C4981

HIV infection

The treatment must be in addition to optimised background therapy; AND
The treatment must be in combination with other antiretroviral agents; AND
Patient must be antiretroviral experienced; AND
The treatment must be co-administered with 200 mg ritonavir twice daily; AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4981

  1. Schedule 4, Part 1, after entry for Trandolapril with Verapamil

    insert:

Trastuzumab C4083

Locally advanced HER2 positive breast cancer

Continuing treatment (3 weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy

Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment

For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg

Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose

 Compliance with Written or Telephone Authority Required procedures
C4093

Early HER2 positive breast cancer

Continuing treatment (3 weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy

Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment

For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg

Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose

 Compliance with Written or Telephone Authority Required procedures
C4104

Locally advanced HER2 positive breast cancer

Continuing treatment (weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy

Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment

For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg

Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose

 Compliance with Written or Telephone Authority Required procedures
C4142

Locally advanced HER2 positive breast cancer

Initial treatment (weekly regimen)

Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy

HER2 positivity must be demonstrated by in situ hybridisation (ISH)

Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form

Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment

For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg

 Compliance with Written Authority Required procedures
C4143

Locally advanced HER2 positive breast cancer

Initial treatment (3 weekly regimen)

Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy

HER2 positivity must be demonstrated by in situ hybridisation (ISH)

Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form

Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment

For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg

 Compliance with Written Authority Required procedures
C4144

Early HER2 positive breast cancer

Initial treatment (3 weekly regimen)

Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone surgery; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy

HER2 positivity must be demonstrated by in situ hybridisation (ISH)

Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form

Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment

For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg

 Compliance with Written Authority Required procedures
C4156

Early HER2 positive breast cancer

Continuing treatment (weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy

Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment

For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg

Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose

 Compliance with Written or Telephone Authority Required procedures
C4164

Early HER2 positive breast cancer

Initial treatment (weekly regimen)

Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone surgery; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy

HER2 positivity must be demonstrated by in situ hybridisation (ISH)

Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form

Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment

For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg

 Compliance with Written Authority Required procedures
C5024

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure

Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, authority approval will be granted for a new loading dose

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment

 Compliance with Written or Telephone Authority Required procedures
C5032

Metastatic (Stage IV) HER2 positive breast cancer

Initial treatment

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The treatment must not be in combination with nab-paclitaxel; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure

Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the patient has Stage IV disease

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment

 Compliance with Written Authority Required procedures
C5041

HER2 positive breast cancer

Grandfathering treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment

 Compliance with Written or Telephone Authority Required procedures
Trastuzumab emtansine C4978

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug

The treatment must not exceed a lifetime total of one continuous course

 Compliance with Written or Telephone Authority Required procedures
C4986

Metastatic (Stage IV) HER2 positive breast cancer

Grandfathering treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR
Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; OR
Patient must have received PBS-subsidised lapatinib for this condition before 1 July 2015; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure

Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment

 Compliance with Written Authority Required procedures
C4987

Metastatic (Stage IV) HER2 positive breast cancer

Initial treatment

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be as monotherapy; AND
Patient must not have received prior treatment with lapatinib; OR
Patient must have developed intolerance to lapatinib of a severity necessitating permanent treatment withdrawal; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure

Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease;
(ii) a copy of the signed patient acknowledgement form;
(iii) dates of treatment with trastuzumab and pertuzumab; and
(iv) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or
(v) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment

Patients who have progressive disease on lapatinib are not eligible to receive PBS-subsidised trastuzumab emtansine

Patients who have developed intolerance to lapatinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised trastuzumab emtansine

If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Travoprost with timolol

    (a)omit:

C4326

Elevated intra‑ocular pressure

The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension

(b)insert in numerical order after existing text:

C5038

Elevated intra-ocular pressure

The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension

  1. Schedule 4, Part 1, entry for Valganciclovir

    substitute:

Valganciclovir C4980

Cytomegalovirus retinitis

Patient must have HIV infection

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4980
C4989

Cytomegalovirus infection and disease

Prophylaxis

Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4989
C5031

Cytomegalovirus infection and disease

Prophylaxis

Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Zidovudine

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:           

    Where the patient is receiving treatment at/from a public hospital

    (b)omit:

C4455

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures
C4469

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

 Compliance with Written or Telephone Authority Required procedures

(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:           

Where the patient is receiving treatment at/from a public hospital

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