National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 1) (No. PB 1 of 2012) (Cth)
PB 1 of 2012
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.1)1
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 7 February 2012
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 1).
(2) This Instrument may also be cited as PB 1 of 2012.
2 Commencement
This Instrument commences on 1 March 2012.
3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1 Amendments
Schedule 1, entry for Abacavir with Lamivudine and Zidovudine
omit from the column headed “Circumstances”:
C3590 C3591 C3592 C3593
substitute:
C3979 C3980 C3981 C3982
Schedule 1, entry for Adefovir
omit from the column headed “Circumstances”:
C3863 C3864
substitute:
C3971 C3972 C3973 C3974
Schedule 1, entry for Amlodipine in the form Tablet 5 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Amlodipine 5 | DO | MP NP | 30 | 5 |
Schedule 1, entry for Amlodipine in the form Tablet 10 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Amlodipine 10 | DO | MP NP | 30 | 5 |
Schedule 1, entry for Amlodipine with valsartan and hydrochlorothiazide
omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP
Schedule 1, entry for Atenolol in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Atenolol-PS | FZ | MP NP | 30 | 5 |
Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Bisoprolol Pfizer | FZ | MP NP | C3234 | 28 | 5 |
Schedule 1, entry for Calcitriol in the form Capsule 0.25 microgram
(a) omit from the column headed “Brand”: Calcitriol-DP substitute: Calciprox
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Calcitriol-PS | FZ | MP NP | C1165 C1166 C1167 C1467 C2636 | 100 | 3 |
Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)
(a) omit:
| Douglas Cefaclor-CD | GM | PDP | 10 | 0 |
(b) omit:
| Douglas Cefaclor-CD | GM | MP | 10 | 1 |
Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Max Quantity 20; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Cephalexin-PS | FZ | PDP | 20 | 0 |
Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Max Quantity 20; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Cephalexin-PS | FZ | MP NP MW | 20 | 1 |
Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Max Quantity 20; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Cephalexin-PS | FZ | PDP | 20 | 0 |
Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Max Quantity 20; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Cephalexin-PS | FZ | MP NP MW | 20 | 1 |
Schedule 1, after entry for Choriogonadotropin alfa in the form Solution for injection 250 micrograms in 0.5 mL pre-filled syringe
insert in the columns in the order indicated:
| Solution for injection 250 micrograms in 0.5 mL pre-filled pen | Injection | Ovidrel | SG | MP See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | D |
Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
(a) omit:
| Ascent Pharmaceuticals Limited | GN | MP NP | C1431 C1432 C1572 C1573 | 14 | 0 |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ciprofloxacin-PS | FZ | MP NP | C1431 C1432 C1572 C1573 | 14 | 0 |
Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Citalopram 20 | DO | MP NP | C1211 | 28 | 5 |
Schedule 1, entry for Citalopram in the form Tablet 40 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Citalopram 40 | DO | MP NP | C1211 | 28 | 5 |
Schedule 1, after entry for Darunavir in the form Tablet 400 mg (as ethanolate)
insert in the columns in the order indicated:
| Tablet 600 mg (as ethanolate) | Oral | Prezista | JC | MP See Note 1 | C3594 C3595 | 120 | 5 | D |
Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL in pre-filled syringe
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”:
C3579 C3580
substitute:
C2758 C3987
Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 5 mg
omit:
| Enalapril-DP 5mg | GN | MP NP | 30 | 5 |
Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 10 mg
omit:
| Enalapril-DP 10mg | GN | MP NP | 30 | 5 |
Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 20 mg
omit:
| Enalapril-DP 20mg | GN | MP NP | 30 | 5 |
Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 0.5 mg
omit from the column headed “Circumstances”:
C3871 C3872
substitute:
C3959 C3960 C3961 C3962
Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg
omit from the column headed “Circumstances”:
C3873 C3874
substitute:
C3963 C3964 C3965 C3966
Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Epirubicin Actavis 10 | TA | MP See Note 1 | See Note 3 | See Note 3 | D |
Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Epirubicin Actavis 20 | TA | MP See Note 1 | See Note 3 | See Note 3 | D |
Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Epirubicin Actavis 50 | TA | MP See Note 1 | See Note 3 | See Note 3 | D |
Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Epirubicin Actavis 100 | TA | MP See Note 1 | See Note 3 | See Note 3 | D |
Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Epirubicin Actavis 200 | TA | MP See Note 1 | See Note 3 | See Note 3 | D |
Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Escitalopram GA | GN | MP NP | C1211 | 28 | 5 |
Schedule 1, entry for Essential Amino Acids Formula
(a) omit from the column headed “Form”: Oral powder 200 g, 2 substitute: Oral powder 200 g
(b) omit from the column headed “Max Quantity”: 3 substitute: 6
Schedule 1, entry for Exemestane in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Exemestane Sandoz | SZ | MP NP | C1541 C2457 | 30 | 5 |
Schedule 1, entry for Exenatide in each of the forms: Injection solution 5 micrograms per dose in pre-filled pen, 60 doses; and Injection solution 10 micrograms per dose in pre-filled pen, 60 doses
omit from the column headed “Circumstances”:
C3536 C3538 C3676 C3677
substitute:
C3540 C3542
Schedule 1, entry for Famotidine in the form Tablet 20 mg
omit:
| Pepcidine M | MK | MP NP | 60 | 5 |
Schedule 1, after entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
insert in the columns in the order indicated:
| Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim) | Injection | TevaGrastim | AS | MP See Note 1 | C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377 C3833 C3834 | 20 | 11 | D |
Schedule 1, after entry for Filgrastim in the form Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
insert in the columns in the order indicated:
| Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim) | Injection | TevaGrastim | AS | MP See Note 1 | C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377 C3833 C3834 | 20 | 11 | D |
Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Fluoxetine-PS | FZ | MP NP | C1211 C1241 | 28 | 5 |
Schedule 1, entry for Foscarnet in the form I.V. infusion containing foscarnet sodium 24 mg per mL, 250 mL
omit from the column headed “Responsible Person”: AP substitute: IX
Schedule 1, entry for Gemcitabine in all forms
omit from the column headed “Circumstances” (leave column blank in all instances):
C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914
Schedule 1, after entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride) [Gemcitabine Kabi]
insert in the columns in the order indicated:
| Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL | Injection | Gemcitabine Ebewe | SZ | MP See Note 1 | See Note 3 | See Note 3 | D |
| Solution concentrate for I.V. infusion 1 g (as hydrochloride) in 25 mL | Injection | Gemcitabine Ebewe | SZ | MP See Note 1 | See Note 3 | See Note 3 | D |
| Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL | Injection | Gemcitabine Ebewe | SZ | MP See Note 1 | See Note 3 | See Note 3 | D |
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 [Max Quantity 30; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959 C3960 C3961 C3962
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 [Max Quantity 30; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959 C3960 C3961 C3962
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 [Max Quantity 30; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959 C3960 C3961 C3962
Schedule 1, entry for Interferon Alfa-2a in the form Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Max Quantity 30; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959 C3960 C3961 C3962
Schedule 1, entry for Interferon Alfa-2b in each of the forms: Solution for injection 10,000,000 I.U. in 1 mL single dose vial; and Solution for injection 18,000,000 I.U. in 3 mL single dose vial
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959 C3960 C3961 C3962
Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen
[Max Quantity 2; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959 C3960 C3961 C3962
Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 25,000,000 I.U. in 2.5 mL single dose vial
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959 C3960 C3961 C3962
Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 60,000,000 I.U. in 1.2 mL multi-dose injection pen
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959 C3960 C3961 C3962
Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen [Max Quantity 2; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959 C3960 C3961 C3962
Schedule 1, entry for Lamivudine in each of the forms: Tablet 100 mg; and Oral solution 5 mg per mL, 240 mL
omit from the column headed “Circumstances”:
C3871 C3872
substitute:
C3959 C3960 C3961 C3962
Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
(a) omit:
| Lamotrigine-DP | GM | MP NP | C1426 | 56 | 5 |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Lamotrigine-PS | FZ | MP NP | C1426 | 56 | 5 |
Schedule 1, after entry for Lignocaine in the form Infusion containing lignocaine hydrochloride 500 mg in 5 mL
insert in the columns in the order indicated:
| Linagliptin | Tablet 5 mg | Oral | Trajenta | BY | MP NP | C3540 | 30 | 5 |
Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
(a) omit:
| Liprace | GM | MP NP | 30 | 5 |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Lisinopril-PS | FZ | MP NP | 30 | 5 |
Schedule 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 10 mg
omit:
| Medroxyhexal | HX | MP NP | 30 | 2 |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit:
| Ascent Pharmaceuticals Limited | GN | MP NP | 100 | 5 |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit:
| Ascent Pharmaceuticals Limited | GN | MP NP | 60 | 5 |
Schedule 1, entry for Milk powder — lactose free formula
omit:
| Oral powder 900 g (Karicare De-Lact) | Oral | Karicare De-Lact | SB | MP NP | C2760 C2762 | P2762 | 5 | 0 |
| MP NP | C2760 C2762 | P2760 | 5 | 5 |
Schedule 1, entry for Oestradiol in the form Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28
omit from the column headed “Responsible Person”: MK substitute: AS
Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Omeprazole-PS | FZ | MP NP | C1177 C1337 C1476 C1533 | P1177 | 30 | 1 |
Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 2]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Panthron | GN | MP NP | C1177 C1337 C1476 C1533 | P1177 | 30 | 2 |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pantoprazole-PS | FZ | MP NP | C1177 C1337 C1476 C1533 | P1177 | 30 | 2 |
Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Panthron | GN | MP NP | C1177 C1337 C1476 C1533 | P1337 P1476 P1533 | 30 | 5 |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pantoprazole-PS | FZ | MP NP | C1177 C1337 C1476 C1533 | P1337 P1476 P1533 | 30 | 5 |
Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pantoprazole-PS | FZ | MP NP | C1533 | 30 | 5 |
Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
omit:
| Paroxetine-DP | GM | MP NP | C1211 C1241 C1862 | 30 | 5 |
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”:
C3867 C3868
substitute:
C3975 C3976 C3977 C3978
Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg
(a) omit:
| Pravastatin 10 | MI | MP | C1540 C3047 | P1540 | 30 | 5 |
| NP | C1540 | 30 | 5 |
(b) omit:
| Pravastatin 10 | MI | MP | C1540 C3047 | P3047 | 30 | 11 |
Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg
(a) omit:
| Pravastatin 20 | MI | MP | C1540 C3047 | P1540 | 30 | 5 |
| NP | C1540 | 30 | 5 |
(b) omit:
| Pravastatin 20 | MI | MP | C1540 C3047 | P3047 | 30 | 11 |
Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg
(a) omit:
| Pravastatin 40 | MI | MP | C1540 C3047 | P1540 | 30 | 5 |
| NP | C1540 | 30 | 5 |
(b) omit:
| Pravastatin 40 | MI | MP | C1540 C3047 | P3047 | 30 | 11 |
Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Prochlorperazine-PS | FZ | PDP MP NP | 25 | 0 |
Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides
omit:
| Oral powder 450 g (Pepti-Junior Gold) | Oral | Pepti-Junior Gold | SB | MP NP | C1034 C1059 C1080 C1092 C1310 C1364 C1670 C2567 C2806 C2811 C2812 C2813 C2814 C2815 | 8 | 5 |
Schedule 1, entry for Ramipril in each of the forms: Capsule 1.25 mg; Capsule 2.5 mg; and Capsule 5 mg
omit:
| Ramipril-DP | GN | MP NP | 30 | 5 |
Schedule 1, entry for Ramipril in the form Capsule 10 mg
(a) omit:
| Ramipril-DP | GN | MP NP | 30 | 5 |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ramipril-PS | FZ | MP NP | 30 | 5 |
Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ranitidine-PS | FZ | MP NP MW | 60 | 5 |
Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Risperidone Pfizer | FZ | MP NP | C1589 C2061 C3083 | P2061 P3083 | 60 | 2 |
Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Risperidone Pfizer | FZ | MP NP | C1589 C2061 C3083 | P1589 | 60 | 5 |
Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Risperidone Pfizer | FZ | MP NP | C1589 C2061 C2272 C3083 | P2061 P3083 | 60 | 2 |
Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Risperidone Pfizer | FZ | MP NP | C1589 C2061 C2272 C3083 | P1589 P2272 | 60 | 5 |
Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Risperidone Pfizer | FZ | MP NP | C1589 C2272 C3083 | P3083 | 60 | 2 |
Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Risperidone Pfizer | FZ | MP NP | C1589 C2272 C3083 | P1589 P2272 | 60 | 5 |
Schedule 1, entry for Risperidone in each of the forms: Tablet 3 mg; and Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Risperidone Pfizer | FZ | MP NP | C1589 C2272 | 60 | 5 |
Schedule 1, entry for Roxithromycin in the form Tablet 150 mg
(a) omit:
| Roxide | HX | PDP | 10 | 0 |
(b) omit:
| Roxide | HX | MP NP | 10 | 1 |
Schedule 1, entry for Roxithromycin in the form Tablet 300 mg
(a) omit:
| Roxide | HX | PDP | 5 | 0 |
(b) omit:
| Roxide | HX | MP NP | 5 | 1 |
Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Sertraline 50 | DO | MP NP | C1211 C1241 C1975 | 30 | 5 |
(b) omit:
| Concorz | HX | MP NP | C1211 | 30 | 5 |
Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Sertraline 100 | DO | MP NP | C1211 C1241 C1975 | 30 | 5 |
(b) omit:
| Concorz | HX | MP NP | C1211 | 30 | 5 |
Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Simvastatin 10 | DO | MP | C1540 C3047 | P1540 | 30 | 5 |
| NP | C1540 | 30 | 5 |
Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Simvastatin 10 | DO | MP | C1540 C3047 | P3047 | 30 | 11 |
Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Simvastatin 20 | DO | MP | C1540 C3047 | P1540 | 30 | 5 |
| NP | C1540 | 30 | 5 |
Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Simvastatin 20 | DO | MP | C1540 C3047 | P3047 | 30 | 11 |
Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Simvastatin 40 | DO | MP | C1540 C3047 | P1540 | 30 | 5 |
| NP | C1540 | 30 | 5 |
Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Simvastatin 40 | DO | MP | C1540 C3047 | P3047 | 30 | 11 |
Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Simvastatin 80 | DO | MP | C1540 C3047 | P1540 | 30 | 5 |
| NP | C1540 | 30 | 5 |
Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Simvastatin 80 | DO | MP | C1540 C3047 | P3047 | 30 | 11 |
(b) omit from the column headed “Responsible Person” for the brand “Simvastatin Sandoz”: CR substitute: SZ
Schedule 1, after entry for Somatropin in the form Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) [Norditropin SimpleXx]
insert in the columns in the order indicated:
| Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative) | Injection | Saizen | SG | MP See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | D |
| Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative) | Injection | Saizen | SG | MP See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | D |
| Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative) | Injection | Saizen | SG | MP See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | D |
Schedule 1, entry for Telbivudine
omit from the column headed “Circumstances”:
C3865 C3866
substitute:
C3967 C3968 C3969 C3970
Schedule 1, entry for Tenofovir
omit from the column headed “Circumstances”:
C3863 C3864 C3865 C3866
substitute:
C3967 C3968 C3969 C3970 C3971 C3972 C3973 C3974
Schedule 1, entry for Tenofovir with emtricitabine and efavirenz
omit from the column headed “Circumstances”:
C3586 C3587 C3588 C3589
substitute:
C3983 C3984 C3985 C3986
Schedule 3, after details relevant to Responsible person code CX
insert:
| DO | Aurobindo Pharma (Australia) Pty Limited | 45 118 452 369 |
Schedule 3, after details relevant to Responsible person code IS
insert:
| IX | Clinect Pty Ltd | 76 150 558 473 |
Schedule 3, details relevant to Responsible person code VP
insert in the column headed “ABN”: 61 140 839 658
Schedule 4, Part 1, entry for Abacavir with Lamivudine and Zidovudine
substitute:
| Abacavir with Lamivudine and Zidovudine | C3979 | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3980 | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures | |
| C3981 | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3981 | |
| C3982 | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3982 |
Schedule 4, Part 1, entry for Adalimumab [Circumstances Code 3743]
omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:
Compliance with
Written Authority
Required procedures
Schedule 4, Part 1, entry for Adalimumab [part of Circumstances Code 3743—line commencing “Continuation of a course of
initial treatment, …….”]
insert in the column headed “Authority Requirements – Part of Circumstances” (currently having no corresponding text):
Compliance with
Written or Telephone Authority Required procedures
Schedule 4, Part 1, entry for Adefovir
substitute:
| Adefovir | C3971 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures |
| C3972 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA | Compliance with Written or Telephone Authority Required procedures |
| C3973 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3973 |
| C3974 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3974 |
Schedule 4, Part 1, entry for Denosumab
substitute:
| Denosumab | C1035 | Bone metastases from breast cancer | Compliance with Authority Required procedures |
| C2758 | Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2758 |
| C3881 | Bone metastases from hormone-resistant prostate cancer | Compliance with Authority Required procedures |
| C3987 | Treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in a woman with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected 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 3987 |
Schedule 4, Part 1, entry for Entecavir
substitute:
| Entecavir | 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 | 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: | 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: | 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 | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962 |
| C3963 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who has failed lamivudine and who satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures |
| C3964 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3964 |
| C3965 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has failed lamivudine and who has detectable HBV DNA | Compliance with Written or Telephone Authority Required procedures |
| C3966 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has failed lamivudine and who has detectable HBV DNA | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3966 |
Schedule 4, Part 1, entry for Exenatide
substitute:
| Exenatide | C3540 | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or (b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3540 |
| C3542 | Treatment of type 2 diabetes, in combination with metformin and a sulfonylurea, in a patient: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with maximally tolerated doses of metformin and a sulfonylurea; or (b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with maximally tolerated doses of metformin and a sulfonylurea; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3542 |
Schedule 4, Part 1, omit entry for Gemcitabine
Schedule 4, Part 1, entry for Interferon Alfa-2a
(a) omit:
| C3869 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient 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; (3) Is not a person 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) | Compliance with Written or Telephone Authority Required procedures |
| C3870 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient 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; (3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3870 |
(b) insert after existing text in the columns in the order indicated:
| 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 | 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: | 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: | 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. | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962 |
Schedule 4, Part 1, entry for Interferon Alfa-2b
(a) omit:
| C3869 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient 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; (3) Is not a person 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) | Compliance with Written or Telephone Authority Required procedures |
| C3870 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient 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; (3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L) | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3870 |
(b) insert after existing text in the columns in the order indicated:
| 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 | 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: | 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: | 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. | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962 |
Schedule 4, Part 1, entry for Lamivudine
omit:
| C3871 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient 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 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 |
| C3872 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient 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 Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g 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 3872 |
substitute:
| 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 | 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: | 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: | 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. | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962 |
Schedule 4, Part 1, after entry for Levonorgestrel
insert:
| Linagliptin | C3540 | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or (b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 3540 |
Schedule 4, Part 1, entry for Peginterferon Alfa-2a
omit:
| C3867 | Where the patient is receiving treatment at/from a private hospital Monotherapy in a patient with chronic hepatitis B and compensated liver disease who satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures |
| C3868 | Where the patient is receiving treatment at/from a public hospital Monotherapy in a patient with chronic hepatitis B who and compensated liver disease who satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3868 |
substitute:
| C3975 | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures |
| C3976 | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who has detectable HBV DNA | Compliance with Written or Telephone Authority Required procedures |
| C3977 | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B 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; (3) Has received no prior peginterferon alfa therapy for the treatment of hepatitis B | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3977 |
| C3978 | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B 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. Treatment is limited to 1 course of treatment for a duration of up to 48 weeks | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3978 |
Schedule 4, Part 1, entry for Telbivudine
substitute:
| Telbivudine | C3967 | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures |
| C3968 | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA | Compliance with Written or Telephone Authority Required procedures | |
| C3969 | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3969 | |
| C3970 | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA. | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3970 |
Schedule 4, Part 1, entry for Tenofovir
omit:
| C3863 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures |
| C3864 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3864 |
| C3865 | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures |
| C3866 | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3866 |
substitute:
| C3967 | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures |
| C3968 | Where the patient is receiving treatment at/from a private hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA | Compliance with Written or Telephone Authority Required procedures |
| C3969 | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3969 |
| C3970 | Where the patient is receiving treatment at/from a public hospital Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3970 |
| C3971 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures |
| C3972 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA | Compliance with Written or Telephone Authority Required procedures |
| C3973 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria: | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3973 |
| C3974 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and 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 3974 |
Schedule 4, Part 1, entry for Tenofovir with emtricitabine and efavirenz
substitute:
| Tenofovir with emtricitabine and efavirenz | C3983 | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3984 | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures | |
| C3985 | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3985 | |
| C3986 | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3986 |
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
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