Instrument number PB 31 of 2008
Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953
I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.
Dated 3rd March 2008
DIANA MACDONELL
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment determination — pharmaceutical benefits
1 Commencement
This instrument commences on 1 April 2008.
2 Amendment of PB 89 of 2007
Schedule 1 amends PB 89 of 2007.
Schedule 1 Amendments
[1] Part 1 of Schedule 1, item dealing with Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)
(a) in the column headed “Brand” insert in alphabetical order:
Adronat
(b) in the column headed “Brand” insert in alphabetical order:
APO-Alendronate
(c) in the column headed “Brand” insert in alphabetical order:
Chem mart Alendronate70mg
(d) in the column headed “Brand” insert in alphabetical order:
Terry White Chemists Alendronate70mg
[2] Part 1 of Schedule 1, item dealing with Amlodipine in the form Tablet 5 mg (as besylate)
(a) in the column headed “Brand” insert in alphabetical order:
APO-Amlodipine
(b) in the column headed “Brand” insert in alphabetical order:
Chem mart Amlodipine
(c) in the column headed “Brand” insert in alphabetical order:
Terry White Chemists Amlodipine
[3] Part 1 of Schedule 1, item dealing with Amlodipine in the form Tablet 10 mg (as besylate)
(a) in the column headed “Brand” insert in alphabetical order:
APO-Amlodipine
(b) in the column headed “Brand” insert in alphabetical order:
Chem mart Amlodipine
(c) in the column headed “Brand” insert in alphabetical order:
Terry White Chemists Amlodipine
[4] Part 1 of Schedule 1, after items dealing with Beclomethasone
insert in the columns in the order indicated:
Benzathine benzylpenicillin | Injection 900 mg in 2.3 mL single use pre-filled syringe | Injection | 10 | .. | Bicillin L-A |
[5] Part 1 of Schedule 1, item dealing with Benzathine Penicillin
omit from the columns in the order indicated:
| Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector) | Injection | 1 | .. | Bicillin L-A Tubex |
[6] Part 1 of Schedule 1, item dealing with Captopril in the forms Tablet 12.5 mg, Tablet 25 mg and Tablet 50 mg
omit from the column headed “Brand” in all instances:
Topace
[7] Part 1 of Schedule 1, item dealing with Carvedilol in the form Tablet 3.125 mg
in the column headed “Brand” insert in alphabetical order:
Dilasig 3.125
[8] Part 1 of Schedule 1, item dealing with Carvedilol in the form Tablet 6.25 mg
in the column headed “Brand” insert in alphabetical order:
Dilasig 6.25
[9] Part 1 of Schedule 1, item dealing with Carvedilol in the form Tablet 12.5 mg
in the column headed “Brand” insert in alphabetical order:
Dilasig 12.5
[10] Part 1 of Schedule 1, item dealing with Carvedilol in the form Tablet 25 mg
in the column headed “Brand” insert in alphabetical order:
Dilasig 25
[11] Part 1 of Schedule 1, item dealing with Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
in the column headed “Brand” insert in alphabetical order:
Cefaclor Sandoz
[12] Part 1 of Schedule 1, item dealing with Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
in the column headed “Brand” insert in alphabetical order:
Cefaclor Sandoz
[13] Part 1 of Schedule 1, item dealing with Cephalexin in the form Granules for oral suspension 125 mg per 5 mL,
100 mL
in the column headed “Brand” insert in alphabetical order:
Cefalexin Sandoz
[14] Part 1 of Schedule 1, item dealing with Cephalexin in the form Granules for oral suspension 250 mg per 5 mL,
100 mL
in the column headed “Brand” insert in alphabetical order:
Cefalexin Sandoz
[15] Part 1 of Schedule 1, item dealing with Cetuximab
insert as first entry for Cetuximab in the columns in the order indicated:
| Solution for I.V. infusion 100 mg in 20 mL | Injection | 1 | .. | Erbitux |
[16] Part 1 of Schedule 1, after item dealing with Cetuximab in the form Solution for I.V. infusion 100 mg in 50 mL
insert in the columns in the order indicated:
| Solution for I.V. infusion 500 mg in 100 mL | Injection | 1 | .. | Erbitux |
[17] Part 1 of Schedule 1, item dealing with Drotrecogin Alfa (activated)
omit from the columns in the order indicated:
| Powder for I.V. infusion 20 mg | Injection | 1 | .. | Xigris |
[18] Part 1 of Schedule 1, item dealing with Enalapril with Hydrochlorothiazide
in the column headed “Brand” insert in alphabetical order:
Enalapril/HCT Sandoz
[19] Part 1 of Schedule 1, item dealing with Famciclovir in the form Tablet 250 mg
(a) omit from the column headed “Maximum quantity”:
21
and substitute:
20
(b) omit from the column headed “Maximum number of repeats”:
..
and substitute:
1
[20] Part 1 of Schedule 1, item dealing with Felodipine in the form Tablet 5 mg (extended release)
in the column headed “Brand” insert in alphabetical order:
Felodipine XR 5
[21] Part 1 of Schedule 1, item dealing with Felodipine in the form Tablet 10 mg (extended release)
in the column headed “Brand” insert in alphabetical order:
Felodipine XR 10
[22] Part 1 of Schedule 1, item dealing with Flucloxacillin in the form Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL
omit from the column headed “Brand”:
Floxapen
[23] Part 1 of Schedule 1, item dealing with Flucloxacillin in the form Powder for injection 500 mg (as sodium)
(a) omit from the column headed “Brand”:
Flopen
(b) in the column headed “Brand” insert in alphabetical order:
Flucil
[24] Part 1 of Schedule 1, item dealing with Flucloxacillin in the form Powder for injection 1 g (as sodium)
(a) omit from the column headed “Brand”:
Aspen Flucil
(b) omit from the column headed “Brand”:
Flopen
(c) insert in the column headed “Brand” in alphabetical order:
Flucil
[25] Part 1 of Schedule 1, item dealing with Gemfibrozil in the form Tablet 600 mg
in the column headed “Brand” insert in alphabetical order:
Pharmacor Gemfibrozil 600
[26] Part 1 of Schedule 1, item dealing with Hypromellose in the form Eye drops 5 mg per mL, 15 mL
omit from the column headed “Brand”:
Isopto Tears
[27] Part 1 of Schedule 1, item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
in the column headed “Brand” insert in alphabetical order:
Irinotecan Sandoz
[28] Part 1 of Schedule 1, item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
in the column headed “Brand” insert in alphabetical order:
Irinotecan Sandoz
[29] Part 1 of Schedule 1, item dealing with Methotrexate in the form Tablet 10 mg
(a) omit from the column headed “Maximum quantity”:
50
and substitute:
15
(b) omit from the column headed “Maximum number of repeats”:
2
and substitute:
1
[30] Part 1 of Schedule 1, after items dealing with Methylphenidate
insert in the columns in the order indicated:
| Capsule containing methylphenidate hydrochloride 20 mg (modified release) | Oral | 30 | 5 | Ritalin LA |
| Capsule containing methylphenidate hydrochloride 30 mg (modified release) | Oral | 30 | 5 | Ritalin LA |
| Capsule containing methylphenidate hydrochloride 40 mg (modified release) | Oral | 30 | 5 | Ritalin LA |
[31] Part 1 of Schedule 1, item dealing with Metronidazole in the form I.V. infusion 500 mg in 100 mL
in the column headed “Brand” insert in alphabetical order:
Metronidazole Sandoz
[32] Part 1 of Schedule 1, item dealing with Oestradiol
omit from the columns in the order indicated:
| Nasal spray containing oestradiol hemihydrate 150 micrograms per actuation, 60 actuations, 4.2 mL | Nasal | 1 | 5 | Aerodiol |
[33] Part 1 of Schedule 1, after items dealing with Paclitaxel
insert in the columns in the order indicated:
Paliperidone | Tablet 3 mg (prolonged release) | Oral | 28 | 5 | Invega |
| Tablet 6 mg (prolonged release) | Oral | 28 | 5 | Invega |
| Tablet 9 mg (prolonged release) | Oral | 28 | 5 | Invega |
[34] Part 1 of Schedule 1, item dealing with Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium heptahydrate)
(a) omit from the column headed “Maximum quantity”:
2
and substitute:
1
(b) omit from the column headed “Maximum number of repeats”:
2
and substitute:
3
[35] Part 1 of Schedule 1, after item dealing with Phenoxymethylpenicillin in the form Oral suspension 125 mg
(as benzathine) per 5 mL, 100 mL
insert in the columns in the order indicated:
| Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL | Oral | 2 | 1 | Abbocillin-V Cilicaine V |
[36] Part 1 of Schedule 1, items dealing with Prochlorperazine
omit from the columns in the order indicated:
| Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5 | Rectal | 1 | 2 | Stemetil |
[37] Part 1 of Schedule 1, item dealing with Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30
(a) in the column headed “Brand” insert in alphabetical order:
Pharmacor Salbutamol 2.5
(b) in the column headed “Brand” insert in alphabetical order:
Salbutamol-GA
(c) in the column headed “Brand” insert in alphabetical order:
Salbutamol Sandoz
[38] Part 1 of Schedule 1, item dealing with Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
(a) in the column headed “Brand” insert in alphabetical order:
Pharmacor Salbutamol 5
(b) in the column headed “Brand” insert in alphabetical order:
Salbutamol-GA
(c) in the column headed “Brand” insert in alphabetical order:
Salbutamol Sandoz
[39] Part 1 of Schedule 1, item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)
omit from the column headed “Maximum number of repeats”:
1
and substitute:
..
[40] Part 2 of Schedule 1, item dealing with Benzathine Penicillin
omit from the columns in the order indicated:
| Injection 900 mg in |
| Syphilis | Injection | 2 | .. | Bicillin L-A Tubex |
[41] Part 2 of Schedule 1, item dealing with Cetuximab
insert as the first entry in the columns in the order indicated:
| Solution for I.V. infusion 100 mg in 20 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Injection | 1 | 6 | Erbitux |
[42] Part 2 of Schedule 1, after item dealing with Cetuximab in the form Solution for I.V. infusion 100 mg in 50 mL
insert in the columns in the order indicated:
| Solution for I.V. infusion 500 mg in 100 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Injection | 1 | 6 | Erbitux |
[43] Part 2 of Schedule 1, item dealing with Famciclovir
insert as first entry in the columns in the order indicated:
| Tablet 250 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of patients with herpes zoster within 72 hours of the onset of the rash | Oral | 21 | .. | Famvir |
[44] Part 2 of Schedule 1, after items dealing with Methadone
insert in the columns in the order indicated:
Methotrexate | Tablet 10 mg |
| For patients requiring doses greater than 20 mg per week | Oral | 50 | 2 | Methoblastin |
[45] Part 2 of Schedule 1, omit items dealing with Pemetrexed
[46] Part 2 of Schedule 1, after items dealing with Temozolomide
insert in the columns in the order indicated:
Terbinafine | Tablet 250 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Proximal or extensive (greater than 80% nail involvement) onychomycosis due to dermatophyte infection where topical treatment has failed, where the infection is proven by microscopy or culture and confirmed by an Approved Pathology Authority not more than 12 months prior to the date of the authority application and where the date of the pathology report is included in the authority application | Oral | 42 | 1 | GenRx Terbinafine Lamisil Tamsil Terbihexal Terbinafine 250 Terbinafine-DP Zabel |
[47] Part 1 of Schedule 2, after items dealing with Diclofenac
insert in the columns in the order indicated:
Fentanyl | Lozenges 200 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 400 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 600 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 800 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 1200 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 1600 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
[48] Part 2 of Schedule 2, after items dealing with Diclofenac
insert in the columns in the order indicated:
Fentanyl | Lozenges 200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 400 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 400 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 800 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 800 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 1200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 1200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 1600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 1600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
[49] Part 1 of Schedule 3, after item dealing with Atropine
insert in the columns in the order indicated:
Benzathine benzylpenicillin | Injection 900 mg in 2.3 mL single use pre-filled syringe | Injection | 10 | .. | Bicillin L-A |
[50] Part 1 of Schedule 3, items dealing with Benzathine Penicillin
omit from the columns in the order indicated:
| Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector) | Injection | 1 | .. | Bicillin L-A Tubex |
[51] Part 1 of Schedule 3, item dealing with Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
in the column headed “Brand” insert in alphabetical order:
Cefaclor Sandoz
[52] Part 1 of Schedule 3, item dealing with Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
in the column headed “Brand” insert in alphabetical order:
Cefaclor Sandoz
[53] Part 1 of Schedule 3, item dealing with Cephalexin in the form Granules for oral suspension 125 mg per 5 mL, 100 mL
in the column headed “Brand” insert in alphabetical order:
Cefalexin Sandoz
[54] Part 1 of Schedule 3, item dealing with Cephalexin in the form Granules for oral suspension 250 mg per 5 mL,
100 mL
in the column headed “Brand” insert in alphabetical order:
Cefalexin Sandoz
[55] Part 1 of Schedule 3, item dealing with Flucloxacillin in the form Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL
omit from the column headed “Brand”:
Floxapen
[56] Part 1 of Schedule 3, item dealing with Flucloxacillin in the form Powder for injection 500 mg (as sodium)
(a) omit from the column headed “Brand”:
Flopen
(b) insert in the column headed “Brand” in alphabetical order:
Flucil
[57] Part 1 of Schedule 3, item dealing with Flucloxacillin in the form Powder for injection 1 g (as sodium)
(a) omit from the column headed “Brand”:
Aspen Flucil
(b) omit from the column headed “Brand”:
Flopen
(c) insert in the column headed “Brand” in alphabetical order:
Flucil
[58] Part 1 of Schedule 3, item dealing with Metronidazole in the form I.V. infusion 500 mg in 100 mL
in the column headed “Brand” insert in alphabetical order:
Metronidazole Sandoz
[59] Part 1 of Schedule 3, after item dealing with Phenoxymethylpenicillin in the form Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL
insert in the columns in the order indicated:
| Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL | Oral | 2 | .. | Abbocillin-V Cilicaine V |
[60] Part 1 of Schedule 3, items dealing with Prochlorperazine
omit from the columns in the order indicated:
| Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5 | Rectal | 1 | .. | Stemetil |