National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 7) (PB 62 of 2016) (Cth)

Case

PB 62 of 2016

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 7)

National Health Act 1953

I, PENNY SHAKESPEARE, 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    12 July   2016

PENNY SHAKESPEARE
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health


1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2016 (No. 7).

(2)        This Instrument may also be cited as PB 62 of 2016.

2          Commencement

This Instrument commences on 1 August 2016.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1     Amendments

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

    omit:

a Zovirax 200 mg GK MP NP C5936 C5942 P5936 50 0 25

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

    (a)omit from the column headed “Circumstances” for the brand “Zovirax 200 mg”:    C5936

    (b)omit from the column headed “Purposes” for the brand “Zovirax 200 mg”:              P5942

  2. Schedule 1, entry for Aciclovir in the form Tablet 800 mg

    omit:

a Zovirax 800 mg GK MP NP C5959 C5967 35 0 35

  1. Schedule 1, entry for Alendronic Acid

    omit from the column headed “Circumstances” (all instances):               C4882  C4885  C4889    substitute:             C6310  C6323  C6327

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

    omit from the column headed “Circumstances” (all instances):               C4070  C4087  C4110    substitute:             C6307  C6315  C6320

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

    omit from the column headed “Circumstances” (all instances):               C4122  C4123  C4133    substitute:             C6306  C6319  C6325

  4. Schedule 1, entry for Alendronic acid with colecalciferol and calcium

    omit from the column headed “Circumstances” (all instances):               C4122  C4123  C4133    substitute:             C6306  C6319  C6325

  5. Schedule 1, entry for Amitriptyline in each of the forms: Tablet containing amitriptyline hydrochloride 10 mg; Tablet containing amitriptyline hydrochloride 25 mg; and Tablet containing amitriptyline hydrochloride 50 mg

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

a ENTRIP RW MP NP 50 2 50

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

    omit from the column headed “Responsible Person”:                 QA       substitute:             OW

  2. Schedule 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride); Capsule
    25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); and Capsule 60 mg (as hydrochloride)

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

a Atomoxetine Amneal EA MP C4578 C6279 56 5 28

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

  1. Schedule 1, entry for Atomoxetine in each of the forms: Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)

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

a Atomoxetine Amneal EA MP C4578 C6279 28 5 28

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

  1. Schedule 1, entry for Azacitidine

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

a Celazadine JU MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Calcitriol

    omit:

a Calcitriol Sandoz SZ MP NP C5089 C5114 C5255 C5401 C5402 100 3 100

  1. Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL

    omit:

Carboplatin Kabi PK MP See Note 3 See
Note 3 		1 D(100)

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

    omit:

Ciazil UA MP NP C4755 28 5 28

  1. Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL pre-filled syringe

    (a)omit from the column headed “Circumstances”:               C4314  C4347   

    (b)insert in numerical order:       C6311  C6326

  2. Schedule 1, entry for Diazepam in the form Tablet 2 mg [Maximum Quantity: 50; Number of Repeats: 0]

    insert in the column headed “Responsible Person” for the brand “Ranzepam”:  RA

  3. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

    omit:

Epirubicin Kabi PK MP See Note 3 See
Note 3 		1 D(100)

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

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

a ESPLER RW MP NP C4937 30 5 30

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

    (a)omit:

a Chem mart Famciclovir CH MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30

(b)omit:

a Terry White Chemists Famciclovir TW MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30

(c)omit:

a Chem mart Famciclovir CH MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56

(d)omit:

a Terry White Chemists Famciclovir TW MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56

  1. Schedule 1, entry for Fluorouracil in each of the forms: Injection 2500 mg in 50 mL; and Injection 5000 mg in 100 mL

    (a)omit from the column headed “Circumstances” (all instances):     See Note 3        substitute:             C6266  C6297

    (b)omit from the column headed “Purposes” (all instances):               See Note 3

  2. Schedule 1, entry for Follitropin alfa

    substitute:

Follitropin alfa Injection 75 I.U. in 0.125 mL pre-filled pen Injection Bemfola FX MP C5027 15 0 5 C(100)
MP C6257 C6321 15 1 5
Injection 150 I.U. in 0.25 mL pre-filled pen Injection Bemfola FX MP C5027 15 0 5 C(100)
MP C6257 C6321 15 1 5
Injection 225 I.U. in 0.375 mL pre-filled pen Injection Bemfola FX MP C5027 15 0 5 C(100)
MP C6257 C6321 15 1 5
Injection 300 I.U. in 0.5 mL multi-dose cartridge Injection Gonal-f Pen SG MP C5027 2 0 1 C(100)
MP C6257 C6321 3 5 1
Injection 300 I.U. in 0.5 mL pre-filled pen Injection Bemfola FX MP C5027 15 0 5 PB(100)
Injection 450 I.U. in 0.75 mL multi-dose cartridge Injection Gonal-f Pen SG MP C5027 2 0 1 C(100)
MP C6257 C6321 3 5 1
Injection 450 I.U. in 0.75 mL pre-filled pen Injection Bemfola FX MP C5027 15 0 5 PB(100)
Injection 900 I.U. in 1.5 mL multi-dose cartridge Injection Gonal-f Pen SG MP C6257 C6321 2 5 1
MP C5027 5 0 1 C(100)

  1. Schedule 1, entry for Follitropin alfa with lutropin alfa

    omit from the column headed “Maximum Quantity”:  7          substitute:             14

  2. Schedule 1, entry for Follitropin beta in each of the forms: Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge; Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge; and Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge

    (a)omit from the column headed “Circumstances”:               C6215  

    (b)insert in numerical order:       C6321

  3. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)

    omit:

Gemcitabine Kabi PK MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Hydroxocobalamin in the form Injection 1 mg (as chloride) in 1 mL

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

Hydroxo-B12 AS MP NP C5840 C5841 C5854 3 0 3

  1. Schedule 1, entry for Isotretinoin in each of the forms: Capsule 10 mg; Capsule 20 mg; and Capsule 40 mg

    omit from the column headed “Responsible Person” for the brand “Oratane”:   AG       substitute:             RF

  2. Schedule 1, entry for Levetiracetam in the form Oral solution 100 mg per mL, 300 mL

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

a APO-Levetiracetam TX MP NP C5215 1 5 1

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

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

    omit:

Prinivil 10 MK MP NP 30 5 30

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

    omit:

Prinivil  20 MK MP NP 30 5 30

  1. Schedule 1, entry for Lutropin alfa

    omit from the column headed “Maximum Quantity”:  7          substitute:             14

  2. Schedule 1, after entry for Morphine in the form Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL

    insert in the columns in the order indicated:

Injection containing morphine hydrochloride 10 mg in 1 mL Injection Morphine Juno JU MP NP MW PDP 5 0 5
Injection containing morphine hydrochloride 20 mg in 1 mL Injection Morphine Juno JU MP NP PDP 5 0 5
Injection containing morphine hydrochloride 50 mg in 5 mL Injection Morphine Juno JU MP NP 5 0 5
Injection containing morphine hydrochloride 100 mg in 5 mL Injection Morphine Juno JU MP NP 5 0 5

  1. Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

    omit:

a Ondansetron Kabi PK MP NP C4077 C4092 1 0 1
MP C5749 1 0 1 C(100)

  1. Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

    omit:

Oxaliplatin Kabi PK MP See Note 3 See
Note 3 		1 D(100)

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

    omit from the column headed “Responsible Person” for the brand “Paralgin” (all instances):       FM       substitute:             OW

  2. Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium)

    (a)omit from the column headed “Schedule Equivalent” (twice occurring):    a

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

PEMETREXED-DRLA RZ MP C4789 C4792 See Note 3 See
Note 3 		1 D(100)

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

Tevatrexed TB MP C4789 C4792 See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium)

    (a)omit from the column headed “Schedule Equivalent” (all instances):          a

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

Tevatrexed TB MP C4789 C4792 See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg

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

Blooms the Chemist Perindopril Arginine IB MP NP 30 5 30

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

IDAPREX ARG 2.5mg TZ MP NP 30 5 30

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

PERINDO ARG 2.5mg TR MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 5 mg

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

Blooms the Chemist Perindopril Arginine IB MP NP 30 5 30

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

IDAPREX ARG 5mg TZ MP NP 30 5 30

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

PERINDO ARG 5mg TR MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg

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

Blooms the Chemist Perindopril Arginine IB MP NP 30 5 30

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

IDAPREX ARG 10mg TZ MP NP 30 5 30

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

PERINDO ARG 10mg TR MP NP 30 5 30

  1. Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate)

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

a Deflectum 5/5 TZ MP NP C4398 C4418 30 5 30

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

a Dynoval 5/5 TR MP NP C4398 C4418 30 5 30

  1. Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate)

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

a Deflectum 5/10 TZ MP NP C4398 C4418 30 5 30

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

a Dynoval 5/10 TR MP NP C4398 C4418 30 5 30

  1. Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate)

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

a Deflectum 10/5 TZ MP NP C4398 C4418 30 5 30

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

a Dynoval 10/5 TR MP NP C4398 C4418 30 5 30

  1. Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate)

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

a Deflectum 10/10 TZ MP NP C4398 C4418 30 5 30

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

a Dynoval 10/10 TR MP NP C4398 C4418 30 5 30

  1. Schedule 1, entry for Perindopril with indapamide

    omit:

Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg Oral Coversyl Plus 5mg/1.25mg SE MP NP C4375 30 5 30
Prexum Combi 5/1.25 RX MP NP C4375 30 5 30

substitute:

Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg Oral a Coversyl Plus 5mg/1.25mg SE MP NP C4375 30 5 30
a Idaprex ARG Combi 5mg/1.25mg TZ MP NP C4375 30 5 30
a Perindo ARG Combi 5mg/1.25mg TR MP NP C4375 30 5 30
a Prexum Combi 5/1.25 RX MP NP C4375 30 5 30

  1. Schedule 1, entry for Quetiapine in each of the forms: Tablet (modified release) 200 mg (as fumarate); Tablet (modified release) 300 mg (as fumarate); and Tablet (modified release) 400 mg (as fumarate)

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

a APO-Quetiapine XR TX MP NP C4246 C5611 C5639 60 5 60

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

    (a)omit:

Chem mart Rabeprazole CH MP NP C5444 C5512 28 5 28

(b)omit:

Terry White Chemists Rabeprazole TW MP NP C5444 C5512 28 5 28

  1. Schedule 1, entry for Raloxifene

    omit from the column headed “Circumstances” (all instances):               C4071   substitute:             C6314

  2. Schedule 1, entry for Ramipril in the form Capsule 10 mg

    omit from the column headed “Brand”:         Ramipril CH     substitute:             Ramipril AN

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

    (a)omit:

GenRx Ranitidine GX MP NP MW 60 5 60

(b)omit:

Ranoxyl FM MP NP MW 60 5 60

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

    (a)omit:

GenRx Ranitidine GX MP NP 30 5 30

(b)omit:

Ranoxyl FM MP NP 30 5 30

  1. Schedule 1, entry for Risedronic Acid in each of the forms: Tablet containing risedronate sodium 5 mg; Tablet containing risedronate sodium 35 mg; Tablet (enteric coated) containing risedronate sodium 35 mg; and Tablet containing risedronate sodium 150 mg

    omit from the column headed “Circumstances” (all instances):               C4882  C4885  C4889    substitute:             C6310  C6323  C6327

  2. Schedule 1, entry for Risedronic acid and calcium

    omit from the column headed “Circumstances” (twice occurring):          C4122  C4123  C4133    substitute:             C6306  C6319  C6325

  1. Schedule 1, entry for Risedronic acid and calcium with colecalciferol

    omit from the column headed “Circumstances”:          C4122  C4123  C4133    substitute:             C6306  C6319  C6325

  2. Schedule 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion 500 mg
    in 50 mL

    omit from the column headed “Circumstances”:          C6187   substitute:             C6309 

  3. Schedule 1, entry for Rituximab

    omit:

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL Injection Mabthera SC RO MP C5998 C6011 C6039 C6161 C6162 C6187 P5998 P6039 1 2 1
MP C5998 C6011 C6039 C6161 C6162 C6187 P6162 P6187 1 6 1
MP C5998 C6011 C6039 C6161 C6162 C6187 P6011 1 7 1
MP C5998 C6008 C6039 C6161 C6162 C6187 P6008 1 7 1 C(100)
MP C5998 C6011 C6039 C6161 C6162 C6187 P6161 1 11 1

substitute:

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL Injection Mabthera SC RO MP C5998 C6011 C6039 C6161 C6162 C6309 P5998 P6039 1 2 1
MP C5998 C6008 C6039 C6161 C6162 C6317 P5998 P6039 1 2 1 C(100)
MP C5998 C6011 C6039 C6161 C6162 C6309 P6162 P6309 1 6 1
MP C5998 C6008 C6039 C6161 C6162 C6317 P6162 P6317 1 6 1 C(100)
MP C5998 C6011 C6039 C6161 C6162 C6309 P6011 1 7 1
MP C5998 C6008 C6039 C6161 C6162 C6317 P6008 1 7 1 C(100)
MP C5998 C6011 C6039 C6161 C6162 C6309 P6161 1 11 1
MP C5998 C6008 C6039 C6161 C6162 C6317 P6161 1 11 1 C(100)

  1. Schedule 1, omit entry for Strontium

  2. Schedule 1, after entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 200; Number of Repeats: 5; Brand: Tacrolimus Sandoz]

    insert in the columns indicated:

Capsule 0.75 mg Oral Tacrolimus Sandoz SZ MP 100 3 100
MP P5569 P5602 200 5 100 C(100)

  1. Schedule 1, after entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 200; Number of Repeats: 5; Brand: Tacrolimus Sandoz]

    insert in the columns indicated:

Capsule 2 mg Oral Tacrolimus Sandoz SZ Mp 100 3 100
MP P5569 P5602 200 5 100 C(100)

  1. Schedule 1, entry for Tacrolimus

    omit:

Capsule 0.5 mg (once daily prolonged release) Oral Prograf XL LL MP 30 3 30
MP P5569 P5602 60
CN5569 CN5602 		5
CN5569 CN5602 		30 C(100)
Capsule 1 mg (once daily prolonged release) Oral Prograf XL LL MP 60 3 60
MP P5569 P5602 120
CN5569 CN5602 		5
CN5569 CN5602 		60 C(100)
Capsule 5 mg (once daily prolonged release) Oral Prograf XL LL MP 30 3 30
MP P5569 P5602 60
CN5569 CN5602 		5
CN5569 CN5602 		30 C(100)

substitute:

Capsule 0.5 mg (once daily prolonged release) Oral a ADVAGRAF XL LQ MP 30 3 30
a Prograf XL LL MP 30 3 30
a ADVAGRAF XL LQ MP P5569 P5602 60
CN5569 CN5602 		5
CN5569 CN5602 		30 C(100)
a Prograf XL LL MP P5569 P5602 60
CN5569 CN5602 		5
CN5569 CN5602 		30 C(100)
Capsule 1 mg (once daily prolonged release) Oral a ADVAGRAF XL LQ MP 60 3 60
a Prograf XL LL MP 60 3 60
a ADVAGRAF XL LQ MP P5569 P5602 120
CN5569 CN5602 		5
CN5569 CN5602 		60 C(100)
a Prograf XL LL MP P5569 P5602 120
CN5569 CN5602 		5
CN5569 CN5602 		60 C(100)
Capsule 5 mg (once daily prolonged release) Oral a ADVAGRAF XL LQ MP 30 3 30
a Prograf XL LL MP 30 3 30
a ADVAGRAF XL LQ MP P5569 P5602 60
CN5569 CN5602 		5
CN5569 CN5602 		30 C(100)
a Prograf XL LL MP P5569 P5602 60
CN5569 CN5602 		5
CN5569 CN5602 		30 C(100)

  1. Schedule 1, omit entry for Telbivudine

  2. Schedule 1, entry for Temozolomide in each of the forms: Capsule 5 mg; Capsule 20 mg; Capsule 100 mg; Capsule 140 mg; and Capsule 180 mg

    omit from the columns headed “Maximum Quantity” and “Number of Repeats” (all instances):      CN4897

  3. Schedule 1, entry for Teriparatide

    omit from the column headed “Circumstances”:          C4407   substitute:             C6305

  4. Schedule 1, entry for Testosterone in all forms

    omit from the column headed “Circumstances”:          C5449  C5460  C5471  C5474  C5511      substitute:             C6304  C6312  C6316  C6322  C6324

  5. Schedule 1, entry for Tobramycin in the form Injection 80 mg (as sulfate) in 2 mL

    (a)omit from the column headed “Form”:                                (as sulfate)

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

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

a Tobramycin Mylan AF MP NP C5446 C5490 C5519 10 1 5

  1. Schedule 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL

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

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

a Tobramycin AN EA MP C5520 56 2 56

  1. Schedule 1, entry for Topotecan

    omit:

Topotecan Kabi PK MP C6238 See Note 3 See
Note 3 		5 D(100)

  1. Schedule 1, entry for Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL

    omit:

Vinorelbine Kabi PK MP See Note 3 See
Note 3 		1 PB(100)

  1. Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

    (a)omit from the column headed “Circumstances” (all instances):     C5656 

    (b)omit from the column headed “Circumstances” (all instances):     C5765  C5796   

    (c)insert in numerical order:       C6308  C6313  C6318

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

    insert:

FX Finox Biotech Australia  98 602 550 274

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

    insert:

LQ Astellas Pharma Australia Pty Ltd  81 147 915 482

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

    insert:

TR Servier Laboratories (Aust.) Pty Ltd  54 004 838 500

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

    insert:

TZ Servier Laboratories (Aust.) Pty Ltd  54 004 838 500

  1. Schedule 4, Part 1, entry for Alendronic Acid

    substitute:

Alendronic acid C6310

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
Patient must be aged 70 years or older.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.
C6323

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.
C6327

Established osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

  1. Schedule 4, Part 1, entry for Alendronic acid with colecalciferol

    substitute:

Alendronic acid with colecalciferol C6306

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6306
C6307

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6307
C6315

Established osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 Compliance with Authority Required procedures - Streamlined Authority Code 6315
C6319

Established osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 Compliance with Authority Required procedures - Streamlined Authority Code 6319
C6320

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
Patient must be aged 70 years or older.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6320
C6325

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
Patient must be aged 70 years or older.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6325

  1. Schedule 4, Part 1, entry for Alendronic acid with colecalciferol and calcium

    substitute:

Alendronic acid with colecalciferol and calcium C6306

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6306
C6319

Established osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 Compliance with Authority Required procedures - Streamlined Authority Code 6319
C6325

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
Patient must be aged 70 years or older.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6325

  1. Schedule 4, Part 1, entry for Denosumab

    (a)omit:

C4314

Osteoporosis

Patient must be aged 70 years or older;

Patient must have a Bone Mineral Density (BMD) T‑score of ‑2.5 or less;

Patient must not receive concomitant treatment with any other PBS‑subsidised anti‑resorptive agent for this condition

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient’s medical records when treatment is initiated

 Compliance with Authority Required procedures – Streamlined Authority Code 4314
C4347

Established osteoporosis

Patient must have fracture due to minimal trauma;

Patient must not receive concomitant treatment with any other PBS‑subsidised anti‑resorptive agent for this condition

The fracture must have been demonstrated radiologically and the year of plain x‑ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient’s medical records when treatment is initiated

A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

 Compliance with Authority Required procedures – Streamlined Authority Code 4347

(b)insert in numerical order after existing text:

C6311

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
Patient must be aged 70 years or older.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6311
C6326

Established osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 Compliance with Authority Required procedures - Streamlined Authority Code 6326

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

    (a)omit:

C6215

Infertility

The condition must be due to hypogonadotrophic hypogonadism; AND
The treatment must be following failure of 6 months' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND
The treatment must be administered with human chorionic gonadotrophin.
Patient must be male.

(b)insert in numerical order after existing text:

C6321

Infertility

The condition must be due to hypogonadotrophic hypogonadism; AND
The treatment must be following failure of 6 months' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND
The treatment must be administered with human chorionic gonadotrophin.

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

    (a)omit:

C6215

Infertility

The condition must be due to hypogonadotrophic hypogonadism; AND
The treatment must be following failure of 6 months' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND
The treatment must be administered with human chorionic gonadotrophin.
Patient must be male.

(b)insert in numerical order after existing text:

C6321

Infertility

The condition must be due to hypogonadotrophic hypogonadism; AND
The treatment must be following failure of 6 months' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND
The treatment must be administered with human chorionic gonadotrophin.

  1. Schedule 4, Part 1, entry for Raloxifene

    substitute:

Raloxifene C6314

Established post-menopausal osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 Compliance with Authority Required procedures - Streamlined Authority Code 6314

  1. Schedule 4, Part 1, entry for Risedronic Acid

    omit:

C4882

Established osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated

A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
C4885

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
C4889

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

Patient must be aged 70 years or older

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated

substitute:

C6310

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
Patient must be aged 70 years or older.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.
C6323

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.
C6327

Established osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

  1. Schedule 4, Part 1, entry for Risedronic acid and calcium

    substitute:

Risedronic acid and calcium C6306

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND

Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND

Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.

The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6306
C6319

Established osteoporosis

Patient must have fracture due to minimal trauma; AND

Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.

The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.

A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 Compliance with Authority Required procedures - Streamlined Authority Code 6319
C6325

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND

Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.

Patient must be aged 70 years or older.

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6325

  1. Schedule 4, Part 1, entry for Risedronic acid and calcium with colecalciferol

    substitute:

Risedronic acid and calcium with colecalciferol C6306

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND

Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND

Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.

The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6306
C6319

Established osteoporosis

Patient must have fracture due to minimal trauma; AND

Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.

The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.

A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 Compliance with Authority Required procedures - Streamlined Authority Code 6319
C6325

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND

Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.

Patient must be aged 70 years or older.

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6325

  1. Schedule 4, Part 1, entry for Rituximab

    omit:

C6187 P6187 Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not be eligible for stem cell transplantation if they have mantle cell lymphoma.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total. 		Compliance with Authority Required procedures - Streamlined Authority Code 6187

substitute:

C6309

Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 6309
C6317 P6317

Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 6317

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

  2. Schedule 4, Part 1, omit entry for Telbivudine

  3. Schedule 4, Part 1, entry for Temozolomide

    omit from the column headed “Conditions Code”:      CN4897

  1. Schedule 4, Part 1, entry for Teriparatide

    omit:

C4407 Severe established osteoporosis
Initial treatment
Must be treated by a specialist; OR
Must be treated by a consultant physician;
Patient must be at very high risk of fracture;
Patient must have a bone mineral density (BMD) T‑score of ‑3.0 or less;
Patient must have had 2 or more fractures due to minimal trauma;
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti‑resorptive agent at adequate doses;
The treatment must be the sole PBS‑subsidised agent;
The treatment must not exceed a lifetime maximum of 18 months therapy
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
If treatment with anti‑resorptive therapy is contraindicated according to the relevant TGA‑approved Product Information, details of the contraindication must be documented in the patient’s medical record at the time treatment with teriparatide is initiated
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti‑resorptive agent, alternate anti‑resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient’s medical record at the time treatment with teriparatide is initiated
Anti‑resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months, strontium ranelate 2 g per day and zoledronic acid 5 mg per annum
Details of prior anti‑resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti‑resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application 		Compliance with Authority Required procedures

substitute:

C6305

Severe established osteoporosis

Initial treatment

Patient must be at very high risk of fracture; AND
Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND
Patient must have had 2 or more fractures due to minimal trauma; AND
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND
The treatment must be the sole PBS-subsidised agent; AND
The treatment must not exceed a lifetime maximum of 18 months therapy.
Must be treated by a specialist; OR
Must be treated by a consultant physician.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy.Details must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.
Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Testosterone

    substitute:

Testosterone C6304

Androgen deficiency

Patient must have an established pituitary or testicular disorder.
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6312

Pubertal induction

Patient must be under 18 years of age.
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6316

Constitutional delay of growth or puberty

Patient must be under 18 years of age.
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6322

Micropenis

Patient must be under 18 years of age.
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6324

Androgen deficiency

Patient must not have an established pituitary or testicular disorder; AND
The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs.
Patient must be aged 40 years or older.
Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
Androgen deficiency is defined as:
(i) testosterone level of less than 6 nmol per litre; OR
(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).
Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.
The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Zoledronic acid

    (a)omit:

C5656

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND
Patient must not receive more than one PBS-subsidised treatment per year.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5656

(b)omit:

C5765

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND
Patient must not receive more than one PBS-subsidised treatment per year.
Patient must be aged 70 years or older.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5765
C5796

Established osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND
Patient must not receive more than one PBS-subsidised treatment per year.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 Compliance with Authority Required procedures - Streamlined Authority Code 5796

(c)insert in numerical order after existing text:

C6308

Corticosteroid-induced osteoporosis

Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND
Patient must not receive more than one PBS-subsidised treatment per year.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6308
C6313

Osteoporosis

Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND
Patient must not receive more than one PBS-subsidised treatment per year.
Patient must be aged 70 years or older.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6313
C6318

Established osteoporosis

Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND
Patient must not receive more than one PBS-subsidised treatment per year.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 Compliance with Authority Required procedures - Streamlined Authority Code 6318

  1. Schedule 5, after entry for Esomeprazole and Clarithromycin and Amoxycillin [GRP-20639]

    insert in the columns in the order indicated:

Hydroxocobalamin GRP-17689 Injection 1 mg (as acetate) in 1 mL Injection Vita-B12
Injection 1 mg (as chloride) in 1 mL Injection Hydroxo-B12
Neo-B12
Morphine GRP-20890 Injection containing morphine hydrochloride 10 mg in 1 mL Injection Morphine Juno
Injection containing morphine sulfate 10 mg in 1 mL Injection Hospira Pty Limited

  1. Schedule 5, entry for Perindopril in the form Tablet containing perindopril arginine 5 mg [GRP-15442]

    (a)insert in alphabetical order in the column headed “Brand”:       Blooms the Chemist Perindopril Arginine

    (b)insert in alphabetical order in the column headed “Brand”:       IDAPREX ARG 5mg

    (c)insert in alphabetical order in the column headed “Brand”:       PERINDO ARG 5mg

  2. Schedule 5, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg [GRP-15525]

    (a)insert in alphabetical order in the column headed “Brand”:       Blooms the Chemist Perindopril Arginine

    (b)insert in alphabetical order in the column headed “Brand”:       IDAPREX ARG 10mg

    (c)insert in alphabetical order in the column headed “Brand”:       PERINDO ARG 10mg

  3. Schedule 5, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg [GRP-15965]

    (a)insert in alphabetical order in the column headed “Brand”:       Blooms the Chemist Perindopril Arginine

    (b)insert in alphabetical order in the column headed “Brand”:       IDAPREX ARG 2.5mg

    (c)insert in alphabetical order in the column headed “Brand”:       PERINDO ARG 2.5mg

  4. Schedule 5, after entry for Perindopril [GRP-15965]

    insert in the columns in the order indicated:

Ramipril GRP-15431 Capsule 10 mg Oral APO‑Ramipril
Chem mart Ramipril
Pharmacor Ramipril 10
Prilace 10
Ramace 10 mg
Ramipril AN
Ramipril‑GA
Ramipril generichealth
Ramipril Sandoz
Ramipril Winthrop
Terry White Chemists Ramipril
Tritace 10 mg
Tryzan Caps 10
Vascalace Caps 10
Tablet 10 mg Oral APO‑Ramipril
Chem mart Ramipril
Ramipril AN
Ramipril RBX Tabs
Ramipril Sandoz
Ramipril Winthrop
Terry White Chemists Ramipril
Tritace
Tryzan Tabs 10
Vascalace 10
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