National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 3) (No. PB 8 of 2013) (Cth)

Case

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

  1. Schedule 1, column headings

omit:       Max Quantity    substitute:          Maximum Quantity

  1. 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”

  1. 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
  1. 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
  1. 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
  1. 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)
  1. 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

  1. 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

  1. Schedule 1, entry for Ibandronic acid

omit from the column headed “Responsible Person” (twice occurring):                                HH        substitute:             RO

  1. 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

  1. 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

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

omit:

Ulcaid RA MP NP 30 5 30
  1. 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
  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
  1. Schedule 3, details relevant to Responsible person code CS

omit:       CSL Biotherapies Pty Ltd         substitute:             bioCSL (Australia) Pty Ltd

  1. 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
  1. 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.

See

Actions
Download as PDF Download as Word Document


Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0