National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 3) (No. PB 8 of 2013) (Cth)
PB 8 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 3)1
National Health Act 1953
I, KIM BESSELL, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 07 February 2013
KIM BESSELL
First Assistant Secretary (Acting)
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 2013 (No. 3).
(2) This Instrument may also be cited as PB 8 of 2013.
2 Commencement
This Instrument commences on 1 March 2013.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
Schedule 1, column headings
omit: Max Quantity substitute: Maximum Quantity
Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids in the form
Oral powder 400 g (EleCare LCP)
delete last row of entry which incorrectly displays only the value: 1 in the column headed “Pack Quantity”
Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity 2; Number of Repeats 0]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Azithromycin | TX | MP NP | C1405 C1838 C1839 | P1838 P1839 | 2 | 0 | 2 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Chem mart Azithromycin | CH | MP NP | C1405 C1838 C1839 | P1838 P1839 | 2 | 0 | 2 |
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Terry White Chemists Azithromycin | TW | MP NP | C1405 C1838 C1839 | P1838 P1839 | 2 | 0 | 2 |
Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity 2; Number of Repeats 2]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Azithromycin | TX | MP NP | C1405 C1838 C1839 | P1405 | 2 | 2 | 2 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Chem mart Azithromycin | CH | MP NP | C1405 C1838 C1839 | P1405 | 2 | 2 | 2 |
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Terry White Chemists Azithromycin | TW | MP NP | C1405 C1838 C1839 | P1405 | 2 | 2 | 2 |
Schedule 1, entry for Diltiazem in each of the forms: Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg; and Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg
omit:
| Diltahexal CD | HX | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| AS-Docetaxel | YA | MP | C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)
omit from the column headed “Responsible Person” for the brand “Escicor 10”: MI substitute: RA
Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)
omit from the column headed “Responsible Person” for the brand “Escicor 20”: MI substitute: RA
Schedule 1, entry for Ibandronic acid
omit from the column headed “Responsible Person” (twice occurring): HH substitute: RO
Schedule 1, entry for Lamotrigine in the form Tablet 25 mg
omit from the column headed “Responsible Person” for the brand “Lamotrigine Aspen 25”: AS substitute: FM
Schedule 1, entry for Lamotrigine in the form Tablet 100 mg
omit from the column headed “Responsible Person” for the brand “Lamotrigine Aspen 100”: AS substitute: FM
Schedule 1, entry for Lamotrigine in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Lamotrigine Aspen 200 | FM | MP NP | C1426 | 56 | 5 | 56 |
Schedule 1, entry for Macrogol 3350
substitute:
| Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | Oral | Movicol | NE | MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3643 See Note 2 | 2 See Note 2 | 0 See Note 2 | 1 |
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3642 See Note 2 | 2 See Note 2 | 3 See Note 2 | 1 | |||||
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P1263 P1613 P2693 P2823 See Note 2 | 1 See Note 2 | 5 See Note 2 | 1 | |||||
| Sachets containing powder for oral solution 17 g, 30 | Oral | MediHealth ClearLax | ON | MP NP | C4170 C4171 C4173 C4176 C4177 C4179 C4180 | P4171 P4173 P4177 P4179 P4180 | 1 | 5 | 1 | |
| MP NP | C4170 C4171 C4173 C4176 C4177 C4179 C4180 | P4170 | 2 | 0 | 1 | |||||
| MP NP | C4170 C4171 C4173 C4176 C4177 C4179 C4180 | P4176 | 2 | 3 | 1 | |||||
| Powder for oral solution 510 g | Oral | MediHealth ClearLax | ON | MP NP | C4170 C4171 C4173 C4176 C4177 C4179 C4180 | P4171 P4173 P4177 P4179 P4180 | 1 | 5 | 1 | |
| OsmoLax | KY | MP NP | C4170 C4171 C4173 C4176 C4177 C4179 C4180 | P4171 P4173 P4177 P4179 P4180 | 1 | 5 | 1 | |||
| MediHealth ClearLax | ON | MP NP | C4170 C4171 C4173 C4176 C4177 C4179 C4180 | P4170 | 2 | 0 | 1 | |||
| OsmoLax | KY | MP NP | C4170 C4171 C4173 C4176 C4177 C4179 C4180 | P4170 | 2 | 0 | 1 | |||
| MediHealth ClearLax | ON | MP NP | C4170 C4171 C4173 C4176 C4177 C4179 C4180 | P4176 | 2 | 3 | 1 | |||
| OsmoLax | KY | MP NP | C4170 C4171 C4173 C4176 C4177 C4179 C4180 | P4176 | 2 | 3 | 1 |
Schedule 1, entry for Nevirapine in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Nevirapine RBX | RA | MP See Note 1 | C3586 C3587 C3588 C3589 | 120 | 5 | 60 | D(100) |
Schedule 1, after entry for Prednisone in the form Tablet 25 mg [Sone]
insert:
| Pregabalin | Capsule 25 mg | Oral | Lyrica | PF | MP NP | C4172 | 1 | 5 | 56 |
| Capsule 75 mg | Oral | Lyrica | PF | MP NP | C4172 | 1 | 5 | 56 | |
| Capsule 150 mg | Oral | Lyrica | PF | MP NP | C4172 | 1 | 5 | 56 | |
| Capsule 300 mg | Oral | Lyrica | PF | MP NP | C4172 | 1 | 5 | 56 |
Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
omit:
| Ulcaid | RA | MP NP | 30 | 5 | 30 |
Schedule 1, after entry for Testosterone in the form Transdermal patches 24.3 mg, 30
insert in the columns in the order indicated:
| Transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 doses | Transdermal | Axiron | LY | MP | C1021 C1022 C1226 | 1 | 5 | 1 |
Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)
omit:
| Venla RBX | RA | MP NP | C1211 | 28 | 0 | 28 |
Schedule 3, details relevant to Responsible person code CS
omit: CSL Biotherapies Pty Ltd substitute: bioCSL (Australia) Pty Ltd
Schedule 4, Part 1, entry for Macrogol 3350
insert after existing text:
| C4170 | P4170 | Constipation Continuing treatment Patient must be receiving palliative care | Compliance with Authority Required procedures - Streamlined Authority Code 4170 |
| C4171 | P4171 | Constipation Patient must have malignant neoplasia | Compliance with Authority Required procedures |
| C4173 | P4173 | Chronic constipation The condition must be inadequately controlled with first line interventions such as bulk-forming agents | Compliance with Authority Required procedures |
| C4176 | P4176 | Constipation Initial treatment Patient must be receiving palliative care; Patient must not receive more than 4 months treatment under this restriction | Compliance with Authority Required procedures - Streamlined Authority Code 4176 |
| C4177 | P4177 | Faecal impaction The condition must be inadequately controlled with first line interventions such as bulk-forming agents | Compliance with Authority Required procedures |
| C4179 | P4179 | Constipation Patient must be receiving palliative care | Compliance with Authority Required procedures |
| C4180 | P4180 | Constipation Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; The condition must be unresponsive to other oral therapies | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Prednisolone with Phenylephrine
insert:
| Pregabalin | C4172 | Neuropathic pain The condition must be refractory to treatment with other drugs | Compliance with Authority Required procedures - Streamlined Authority Code 4172 |
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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