National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 5) (No. PB 37 of 2012) (Cth)
PB 37 of 2012
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.5)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 June 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. 5).
(2) This Instrument may also be cited as PB 37 of 2012.
2 Commencement
This Instrument commences on 1 July 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, after entry for Amino acid formula with vitamins and minerals without methionine in the form Oral powder 500 g
(XMET Maxamum)
insert in the columns in the order indicated:
| Oral liquid 125 mL, 30 (HCU Lophlex LQ 20) | Oral | HCU Lophlex LQ 20 | SB | MP NP | C1314 | 3 | 5 |
Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Oral powder 500 g (XPhen, Tyr Maxamum)
insert in the columns in the order indicated:
| Oral liquid 125 mL, 30 (TYR Lophlex LQ 20) | Oral | TYR Lophlex LQ 20 | SB | MP NP | C1453 | 3 | 5 |
Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Oral powder 500 g (MSUD Maxamum)
insert in the columns in the order indicated:
| Oral liquid 125 mL, 30 (MSUD Lophlex LQ 20) | Oral | MSUD Lophlex LQ 20 | SB | MP NP | C1220 | 3 | 5 |
Schedule 1, entry for Amino acids—synthetic, formula
substitute:
| Amino acids — synthetic, formula | Oral powder 400 g (EleCare) | Oral | EleCare | AB | MP NP | C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | P1687 P1688 P4033 P4034 P4035 P4036 P4037 P4038 P4039 | 8 | 5 |
| MP NP | C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | P2734 P2735 | 12 | 5 | |||||
| Oral powder 400 g (Neocate Advance) | Oral | Neocate Advance | SB | MP NP | C1687 C1688 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | 8 | 5 | ||
| Oral powder 400 g (Neocate Advance Tropical Flavour) | Oral | Neocate Advance Tropical Flavour | SB | MP NP | C1687 C1688 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | 8 | 5 | ||
| Oral powder 400 g (Neocate Advance Vanilla) | Oral | Neocate Advance Vanilla | SB | MP NP | C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | P1687 P1688 P4033 P4034 P4035 P4036 P4037 P4038 P4039 | 8 | 5 | |
| MP NP | C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | P2734 P2735 | 12 | 5 |
Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
substitute:
| Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | Oral powder 400 g (Neocate LCP) | Oral | Neocate LCP | SB | MP NP | C1687 C1688 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | 8 | 5 |
| Oral powder 400 g (EleCare LCP) | Oral | EleCare LCP | AB | MP NP | C1687 C1688 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | 8 | 5 |
Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and
medium chain triglycerides
substitute:
| Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides | Oral powder 400 g (Neocate Gold) | Oral | Neocate Gold | SB | MP NP | C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | P1687 P1688 P4033 P4034 P4035 P4036 P4037 P4038 P4039 | 8 | 5 |
| MP NP | C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039 | P2734 P2735 | 12 | 5 |
Schedule 1, entry for Apixaban
substitute:
| Apixaban | Tablet 2.5 mg | Oral | Eliquis | BQ | MP NP | C3957 C3991 C4043 C4044 C4046 | P3957 P4043 | 20 | 0 |
| MP NP | C3957 C3991 C4043 C4044 C4046 | P3991 P4044 | 30 | 0 | |||||
| MP NP | C3957 C3991 C4043 C4044 C4046 | P4046 | 60 | 0 |
Schedule 1, entry for Bortezomib
omit from the column headed “Form”: (with any determined brand of sodium chloride injection as the required solvent)
Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g
(a) omit from the column headed “Responsible Person” for the brand “PAA” (twice occurring): NM substitute: IQ
(b) omit from the column headed “Responsible Person” for the brand “Viscotears” (twice occurring): NV substitute: AQ
Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, single dose units 0.6 mL, 30
omit from the column headed “Responsible Person”: NV substitute: AQ
Schedule 1, entry for Cefepime in the form Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)
omit:
| Maxipime | BQ | MP NP | C1427 | 10 | 0 |
Schedule 1, entry for Ceftriaxone in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ceftriaxone-AFT | AE | MP NP | C1169 C1846 C1847 | 5 | 0 |
Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Loxip 500 | DO | MP NP | C1431 C1432 C1572 C1573 | 14 | 0 |
Schedule 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Loxip 750 | DO | 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”:
| A-Citalopram | TA | MP NP | C1211 | 28 | 5 |
Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pharmacor Clopidogrel 75 | CR | MP NP | C1719 C1720 C1721 C1722 C1723 C1724 | 28 | 5 |
Schedule 1, entry for Dabigatran etexilate
substitute:
| Dabigatran etexilate | Capsule 75 mg (as mesilate) | Oral | Pradaxa | BY | MP NP | C3957 C4047 C4048 | P3957 | 20 | 0 |
| MP NP | C3957 C4047 C4048 | P4047 | 20 | 1 | |||||
| MP NP | C3957 C4047 C4048 | P4048 | 60 | 0 | |||||
| Capsule 110 mg (as mesilate) | Oral | Pradaxa | BY | MP NP | C3957 C4047 C4048 | P3957 | 20 | 0 | |
| MP NP | C3957 C4047 C4048 | P4047 | 20 | 1 | |||||
| MP NP | C3957 C4047 C4048 | P4048 | 60 | 0 |
Schedule 1, entry for Denosumab in the form Injection 120 mg in 1.7 mL
omit from the column headed “Circumstances”:
C3881
insert in numerical order:
C4051
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL [DBL Docetaxel Concentrated Injection]
insert in numerical order in the column headed “Circumstances”:
C3892
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [DBL Docetaxel Concentrated Injection]
insert in numerical order in the column headed “Circumstances”:
C3892
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [DBL Docetaxel Concentrated Injection]
insert in numerical order in the column headed “Circumstances”:
C3892
Schedule 1, entry for Etonogestrel
omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP MW
Schedule 1, entry for Fentanyl
omit:
| Lozenges 200 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | 3 | 0 |
| Lozenges 400 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | 3 | 0 |
| Lozenges 600 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | 3 | 0 |
| Lozenges 800 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | 3 | 0 |
| Lozenges 1200 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | 3 | 0 |
| Lozenges 1600 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | 3 | 0 |
| Lozenges 200 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | 2 | 0 |
| Lozenges 400 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | 2 | 0 |
| Lozenges 600 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | 2 | 0 |
| Lozenges 800 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | 2 | 0 |
| Lozenges 1200 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | 2 | 0 |
| Lozenges 1600 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | 2 | 0 |
substitute:
| Lozenge 200 micrograms (as citrate) | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 9 | 0 |
| MP NP | C3663 C3664 | P3664 | 60 | 0 | ||||
| Lozenge 400 micrograms (as citrate) | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 9 | 0 |
| MP NP | C3663 C3664 | P3664 | 60 | 0 | ||||
| Lozenge 600 micrograms (as citrate) | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 9 | 0 |
| MP NP | C3663 C3664 | P3664 | 60 | 0 | ||||
| Lozenge 800 micrograms (as citrate) | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 9 | 0 |
| MP NP | C3663 C3664 | P3664 | 60 | 0 | ||||
| Lozenge 1200 micrograms (as citrate) | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 9 | 0 |
| MP NP | C3663 C3664 | P3664 | 60 | 0 | ||||
| Lozenge 1600 micrograms (as citrate) | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 9 | 0 |
| MP NP | C3663 C3664 | P3664 | 60 | 0 |
Schedule 1, entry for Gefitinib
substitute:
| Gefitinib | Tablet 250 mg | Oral | Iressa | AP | MP | C4029 C4030 | 30 | 3 |
Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Accu-Chek Performa)
insert in the columns in the order indicated:
| Test strips, 100 (BGStar) | For external use | BGStar | SW | MP NP | 1 | 5 |
| MP | P3035 | 1 | 11 |
Schedule 1, entry for Hypromellose in the form Eye drops 3 mg per mL, 15 mL
(a) omit from the column headed “Responsible Person” for the brand “Genteal” (twice occurring): NV substitute: AQ
(b) omit from the column headed “Responsible Person” for the brand “In a Wink Moisturising” (twice occurring): NM substitute: IQ
Schedule 1, entry for Hypromellose with Carbomer 980 in the form Ocular lubricating gel 3 mg-2 mg per g, 10 g
(a) omit from the column headed “Responsible Person” for the brand “Genteal gel” (twice occurring): NV substitute: AQ
(b) omit from the column headed “Responsible Person” for the brand “HPMC PAA” (twice occurring): NM substitute: IQ
Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Irinotecan Alphapharm | AF | MP | C3184 | See Note 3 | See Note 3 | D |
Schedule 1, entry for Levetiracetam in the form Tablet 250 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Kerron 250 | DO | MP NP | C2664 | 60 | 5 |
Schedule 1, entry for Levetiracetam in the form Tablet 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Kerron 500 | DO | MP NP | C2664 | 60 | 5 |
Schedule 1, entry for Levetiracetam in the form Tablet 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Kerron 1000 | DO | MP NP | C2664 | 60 | 5 |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Metformin Pfizer | FZ | MP NP | 100 | 5 |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Metformin Pfizer | FZ | MP NP | 60 | 5 |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Metformin Pfizer | FZ | MP NP | 90 | 5 |
Schedule 1, entry for Mirtazapine in each of the forms: Tablet 30 mg; and Tablet 45 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Mirtazapine GH | GQ | MP NP | C1211 | 30 | 5 |
Schedule 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Moclobemide-PS | FZ | MP NP | C1211 | 60 | 5 |
Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pharmacor Olanzapine 2.5 | CR | MP NP | C1589 C2044 | 28 | 5 |
Schedule 1, entry for Olanzapine in the form Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pharmacor Olanzapine 5 | CR | MP NP | C1589 C2044 | 28 | 5 |
Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pharmacor Olanzapine 7.5 | CR | MP NP | C1589 C2044 | 28 | 5 |
Schedule 1, entry for Olanzapine in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pharmacor Olanzapine 10 | CR | MP NP | C1589 C2044 | 28 | 5 |
Schedule 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium) [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 Sandoz | SZ | MP NP | C1177 C1337 C1476 C1533 | P1177 | 30 | 1 |
Schedule 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium) [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Omeprazole Sandoz | SZ | MP NP | C1177 C1337 C1476 C1533 | P1337 P1476 P1533 | 30 | 5 |
Schedule 1, entry for Ondansetron
omit:
| Ondansetron | Tablet (orally disintegrating) 4 mg | Oral | Ondansetron ODT-DRLA | RZ | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 |
| MP NP | C3050 C3611 | P3611 | 10 | 1 | |||||
| Tablet (orally disintegrating) 8 mg | Oral | Ondansetron ODT-DRLA | RZ | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 | |
| MP NP | C3050 C3611 | P3611 | 10 | 1 |
substitute:
| Ondansetron | Tablet (orally disintegrating) 4 mg | Oral | Ondansetron ODT-DRLA | RZ | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 |
| Onsetron ODT 4 | WQ | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 | |||
| Ondansetron ODT-DRLA | RZ | MP NP | C3050 C3611 | P3611 | 10 | 1 | |||
| Onsetron ODT 4 | WQ | MP NP | C3050 C3611 | P3611 | 10 | 1 | |||
| Tablet (orally disintegrating) 8 mg | Oral | Ondansetron ODT-DRLA | RZ | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 | |
| Onsetron ODT 8 | WQ | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 | |||
| Ondansetron ODT-DRLA | RZ | MP NP | C3050 C3611 | P3611 | 10 | 1 | |||
| Onsetron ODT 8 | WQ | MP NP | C3050 C3611 | P3611 | 10 | 1 |
Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Max Quantity 4; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Zondan | GM | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 |
Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Max Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Zondan | GM | MP NP | C3050 C3611 | P3611 | 10 | 1 |
Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Max Quantity 4; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Zondan | GM | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 |
Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Max Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Zondan | GM | MP NP | C3050 C3611 | P3611 | 10 | 1 |
Schedule 1, omit entry for Polygeline
Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides
substitute:
| Protein hydrolysate formula with medium chain triglycerides | Oral powder 400 g (Alfaré) | Oral | Alfaré | NT | MP NP | C1034 C1059 C1068 C1080 C1092 C1310 C1364 C1670 C2567 C4040 C4041 C4042 | 8 | 5 |
| Oral powder 450 g (Karicare Aptamil Pepti-Junior Gold) | Oral | Karicare Aptamil Pepti-Junior Gold | NU | MP NP | C1034 C1059 C1080 C1092 C1310 C1364 C1670 C2567 C4040 C4041 C4042 | 8 | 5 |
Schedule 1, entry for Rivaroxaban
substitute:
| Rivaroxaban | Tablet 10 mg | Oral | Xarelto | BN | MP NP | C3957 C3993 C4047 C4048 C4050 | P3957 | 10 | 0 |
| MP NP | C3957 C3993 C4047 C4048 C4050 | P4047 | 10 | 1 | |||||
| MP NP | C3957 C3993 C4047 C4048 C4050 | P4050 | 15 | 0 | |||||
| MP NP | C3957 C3993 C4047 C4048 C4050 | P4048 | 15 | 1 | |||||
| MP NP | C3957 C3993 C4047 C4048 C4050 | P3993 | 30 | 0 |
Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 0]
(a) omit from the column headed “Responsible Person” for the brand “Terbihexal”: SZ substitute: HX
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Terbinafine Sandoz | SZ | MP NP | C2191 C2865 C3244 | P2865 P3244 | 42 | 0 |
Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 1]
(a) omit from the column headed “Responsible Person” for the brand “Terbihexal”: SZ substitute: HX
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Terbinafine Sandoz | SZ | MP NP | C2191 C2865 C3244 | P2191 | 42 | 1 |
Schedule 1, entry for Teriparatide
omit all codes from the column headed “Circumstances” and substitute:
C4031 C4032
Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL
omit from the column headed “Circumstances”:
C3881 C3882
insert in numerical order:
C4051 C4052
Schedule 3, details relevant to Responsible person code GH
omit:
Goldshield Healthcare (Australia) Pty Limited
substitute:
Mercury Pharma (Australia) Pty Limited
Schedule 4, Part 1, entry for Amino acids—synthetic, formula
(a) omit:
| C2805 | P2805 | Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2806 | P2806 | Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows' milk protein, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2807 | P2807 | Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2808 | P2808 | Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2809 | P2809 | Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2810 | P2810 | Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
(b) insert in numerical order after existing text:
| C4033 | P4033 | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4034 | P4034 | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4035 | P4035 | Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4036 | P4036 | Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4037 | P4037 | Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4038 | P4038 | Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4039 | P4039 | Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
substitute:
| Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | C1687 | Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed | Compliance with Authority Required procedures |
| C1688 | Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Compliance with Authority Required procedures | |
| C4033 | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures | |
| C4034 | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures | |
| C4035 | Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures | |
| C4036 | Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4037 | Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4038 | Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4039 | Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and
medium chain triglycerides
substitute:
| Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides | C1687 | P1687 | Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed | Compliance with Authority Required procedures |
| C1688 | P1688 | Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Compliance with Authority Required procedures | |
| C2734 | P2734 | Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where: eosinophilic oesophagitis is demonstrated by the following criteria: (i) chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and (ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and (iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies; the date of birth of the patient is included in the authority application; treatment with oral steroids is not commenced during the period of initial treatment | Compliance with Authority Required procedures | |
| C2735 | P2735 | Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS-subsidised treatment, and where: response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies; the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment | Compliance with Authority Required procedures | |
| C4033 | P4033 | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures | |
| C4034 | P4034 | Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures | |
| C4035 | P4035 | Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures | |
| C4036 | P4036 | Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4037 | P4037 | Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4038 | P4038 | Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4039 | P4039 | Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Apixaban
substitute:
| Apixaban | C3957 | P3957 | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy; | Compliance with Authority Required procedures |
| C3991 | P3991 | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy; | Compliance with Authority Required procedures | |
| C4043 | P4043 | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 10 days supply to complete a course of treatment | Compliance with Authority Required procedures | |
| C4044 | P4044 | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 15 days supply to complete a course of treatment | Compliance with Authority Required procedures | |
| C4046 | P4046 | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete a course of treatment | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Dabigatran etexilate
substitute:
| C3957 | P3957 | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy | Compliance with Authority Required procedures |
| C4047 | P4047 | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 20 days supply to complete a course of treatment | Compliance with Authority Required procedures |
| C4048 | P4048 | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete a course of treatment | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Denosumab
(a) omit:
| C3881 | Bone metastases from hormone-resistant prostate cancer | Compliance with Authority Required procedures |
(b) insert in numerical order after existing text:
| C4051 | Bone metastases from castration-resistant prostate cancer | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Gefitinib
substitute:
| Gefitinib | C4029 | Initial PBS-subsidised treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of 2 or less, where: (1) disease progression has occurred following treatment with at least 1 chemotherapy agent; and (2) there is evidence that the patient has an activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material | Compliance with Authority Required procedures |
| C4030 | Continuing PBS-subsidised treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of 2 or less, where the patient has previously been issued with an authority prescription for gefitinib | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Protein hydrolysate formula with medium chain triglycerides
(a) omit:
| C2806 | Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows' milk protein, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2811 | Initial treatment, for up to 3 months, for intolerance (not infant colic) to both cows' milk protein and soy protein in a child up to the age of 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a soy protein as the principal formula, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2812 | Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in a child up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2813 | Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in a child aged 2 years and over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2814 | Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides and soy protein is not tolerated or is likely not to be tolerated, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2815 | Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child has been assessed by a paediatric gastroenterologist or specialist allergist, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
(b) insert in numerical order after existing text:
| C4040 | Initial treatment by, or in consultation with, a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child up to the age of 24 months. The child should have failed to respond to a strict soy-based cows' milk protein free diet. The date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4041 | Continuing treatment by, or in consultation with, a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child up to the age of 24 months, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides. The date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4042 | Treatment by a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Rivaroxaban
substitute:
| Rivaroxaban | C3957 | P3957 | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy | Compliance with Authority Required procedures |
| C3993 | P3993 | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days of therarpy | Compliance with Authority Required procedures | |
| C4047 | P4047 | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 20 days supply to complete a course of treatment | Compliance with Authority Required procedures | |
| C4048 | P4048 | Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete a course of treatment | Compliance with Authority Required procedures | |
| C4050 | P4050 | Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Teriparatide
substitute:
| Teriparatide | C4031 | Initial treatment, as the sole PBS-subsidised agent, by a specialist or consultant physician, for severe, established osteoporosis in a patient with a very high risk of fracture who: (a) has a bone mineral density (BMD) T-score of -3.0 or less; and (b) has had 2 or more fractures due to minimal trauma; and (c) has experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses 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 Therapeutic Goods Administration-approved Product Information, details of the contraindication must be provided at the time of application If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of 1 anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details of toxicities including severity must be provided at the time of application 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, disodium etidronate 200 mg with calcium carbonate 1.25 g per day, 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) and site(s), the symptoms associated with the fracture(s) which developed during the course of anti-resorptive therapy, and the score of the qualifying BMD measurement must be provided to Medicare Australia at the time of application | Compliance with Authority Required procedures |
| C4032 | Continuing treatment for severe established osteoporosis where the patient has previously been issued with an authority prescription for this drug Teriparatide must only be used for a lifetime maximum of 18 months therapy (18 pens). Up to a maximum of 18 pens will be reimbursed through the PBS | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Zoledronic acid
(a) omit:
| C3881 | Where the patient is receiving treatment at/from a private hospital Bone metastases from hormone-resistant prostate cancer | Compliance with Written or Telephone Authority Required procedures |
| C3882 | Where the patient is receiving treatment at/from a public hospital Bone metastases from hormone-resistant prostate cancer | Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3882 |
(b) insert in numerical order after existing text:
| C4051 | Where the patient is receiving treatment at/from a private hospital Bone metastases from castration-resistant prostate cancer | Compliance with Written or Telephone Authority Required procedures |
| C4052 | Where the patient is receiving treatment at/from a public hospital Bone metastases from castration-resistant prostate cancer | Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4052 |
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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