National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 30 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 30 of 2008

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) 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 subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated    3^rd March                2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1              Commencement

This instrument commences on 1 April 2008.

2              Amendment of PB 88 of 2007

Schedule 1 amends PB 88 of 2007.

Schedule 1        Amendments

[1]       Schedule 1, after item dealing with Beclomethasone

insert in the columns in the order indicated:

Benzathine benzylpenicillin —

[2]       Schedule 1, item dealing with Docetaxel

omit from “Column 3”:

Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where the patient was receiving prior treatment with other chemotherapy for androgen independent (hormone refractory) metastatic carcinoma of the prostate at 1 November 2007, and where docetaxel is administered in three weekly cycles

[3]       Schedule 1, item dealing with Famciclovir

insert in “Column 3” after “In respect of the tablet 250 mg:  In compliance with authority procedures set out in subparagraph 14 (d):”:

Episodic treatment of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

[4]       Schedule 1, item dealing with Methylphenidate

insert in “Column 3” after existing text:

In respect of the capsule containing methylphenidate hydrochloride 20 mg (modified release), capsule containing methylphenidate hydrochloride 30 mg (modified release) and capsule containing methylphenidate hydrochloride 40 mg (modified release):

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of attention deficit hyperactivity disorder in a patient aged 6 to 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 8 hours

[5]       Schedule 1, item dealing with Oestradiol

omit from “Column 3”:

nasal spray containing oestradiol hemihydrate 150 micrograms per actuation, 60 actuations, 4.2 mL,

[6]       Schedule 1, after item dealing with Paclitaxel

insert in the columns in the order indicated:

Paliperidone	In compliance with authority procedures set out in subparagraph 14 (d):
1589	Schizophrenia

[7]       Schedule 1, item dealing with Pemetrexed

omit all text from “Column 3”and substitute:

In compliance with authority procedures set out in subparagraph 14 (d):

Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is included in the authority application

Mesothelioma, in combination with cisplatin, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is included in the authority application

[8]       Schedule 1, item dealing with Tacrolimus

insert in “Column 3” after existing text:

Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with tacrolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application

[9]       Schedule 1, item dealing with Terbinafine

insert in “Column 3” after “In compliance with authority procedures set out in subparagraph 14 (d):”:

Treatment of a dermatophyte infection in an Aboriginal or a Torres Strait Islander person where topical treatment has failed

[10]     Schedule 1A, after item dealing with Diclofenac

insert in the columns in the order indicated:

Fentanyl	In compliance with authority procedures set out in subparagraph 14 (d):
Initial supply for dose titration 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
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
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

[11]     Schedule 2, after Atropine

insert in the columns in the order indicated:

Benzathine benzylpenicillin —

[12]     Schedule 6, after Sildenafil

insert:

Sitaxentan