National Health Act 1953 Declaration under subsection 85(2) (No. PB 7 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

National Health Act 1953

PHARMACEUTICAL BENEFITS

DECLARATION UNDER SUBSECTION 85(2)

No. PB 7 of 2007

I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to subsection 85(2) of the National Health Act 1953, hereby make the following Declaration:

1.  This Declaration commences on 1 February 2007.

1. Declaration No. PB 46 of 2006 under subsection 85(2) of the National Health Act 1953 made on 7 November 2006 with effect from 1 December 2006, as amended by Declaration No. PB 2 of 2007 under subsection 85(2) of the National Health Act 1953 made on 1 December 2006 with effect from 1 January 2007 is, in this Declaration, referred to as the Principal Declaration.

1. Paragraph 3 of the Principal Declaration is amended by omitting:

“(c) in relation to ramipril: captopril or enalapril maleate or fosinopril sodium or lisinopril or perindopril arginine or perindopril erbumine or quinapril hydrochloride or trandolapril;”

and substituting:

“(c) in relation to ramipril (pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg): captopril or enalapril maleate or fosinopril sodium or lisinopril or perindopril arginine or perindopril erbumine or quinapril hydrochloride or ramipril  (tablet 1.25 mg or tablet 2.5 mg or tablet 5 mg or capsule 10 mg) or trandolapril;”.

1. Schedule 1 to the Principal Declaration is amended:

(a) in respect of the pharmaceutical benefit Carvedilol, by omitting the details in column 2 and by substituting the following details:

Column 2 − Circumstances (if any) specified for the purposes of section 88A of the Act:

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

Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated

Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002

(b) in respect of the pharmaceutical benefit Ciprofloxacin Hydrochloride, by inserting in column 2, after the details in respect of the tablet equivalent to 500 mg ciprofloxacin and tablet equivalent to 750 mg ciprofloxacin, the following details:

Column 2 − Circumstances (if any) specified for the purposes of section 88A of the Act:

In respect of the ear drops equivalent to 3 mg ciprofloxacin per mL, 5 mL:

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

Treatment of chronic suppurative otitis media in an Aboriginal or a Torres Strait Islander person aged 1 year and older

(c) in respect of the pharmaceutical benefit Modafinil, by omitting the details in column 2 and by substituting the following details:

Column 2 − Circumstances (if any) specified for the purposes of section 88A of the Act:

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

Initial treatment, by a qualified sleep medicine practitioner or neurologist, of patients with narcolepsy where:
(i) intolerance to dexamphetamine sulfate of a severity necessitating permanent treatment withdrawal develops; or
(ii) therapy with dexamphetamine sulfate poses an unacceptable medical risk, as indicated by the presence of any 1 of the following:
(a) a psychiatric disorder;
(b) a cardiac disorder;
(c) a history of substance abuse;
(d) glaucoma;
(e) any other absolute contraindication to dexamphetamine sulfate as specified in the Therapeutic Goods Administration-approved Product Information; and
where the patient meets the following definition of narcolepsy:
excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months, and:
(i) a definite history of cataplexy and a Multiple Sleep Latency Test (MSLT), conducted following at least 6 hours of sleep, with a mean sleep latency less than or equal to 8 minutes; or
(ii) a MSLT, conducted following at least 6 hours of sleep, with a mean sleep latency less than or equal to 8 minutes and 2 or more sleep onset rapid eye movement (REM) periods; or
(iii) an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; and
where the following conditions apply:
the MSLT is preceded by nocturnal polysomnography;
the polysomnography test and the MSLT are conducted by, or under the supervision of, a qualified sleep medicine practitioner;
the EEG is conducted by, or under the supervision of, a neurologist;
the authority application includes the following:
(a) a completed copy of the appropriate Modafinil (Modavigil) PBS Authority Application - Supporting Information Form; and
(b) details of the contraindication or intolerance to dexamphetamine sulfate; and
(c) either the result and date of the polysomnography test and the MSLT, or the result and date of the EEG;
the polysomnography and MSLT, or the EEG, test reports are provided with the authority application

In compliance with authority procedures set out in subsubparagraph 14 (d)(i)  or 14 (d)(ii):

Continuing treatment of narcolepsy, where the patient has previously been issued with an authority prescription for this drug

(d) In respect of the pharmaceutical benefit Riluzole, by omitting the details in column 2 and by substituting the following details:

Column 2 − Circumstances (if any) specified for the purposes of section 88A of the Act:

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

Initial treatment of amyotrophic lateral sclerosis, as diagnosed by a neurologist, in patients with disease duration of 2 years or less who have at least 60 percent of predicted forced vital capacity within 2 months prior to commencing riluzole therapy, and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow, and where the date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) are included in the authority application

Continuing treatment of amyotrophic lateral sclerosis in patients who have previously been issued with an authority prescription for this drug and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow

Dated this 5^th day of January 2007.

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing