National Health Act 1953 Declaration under subsection 85(2) (No. PB 2 of 2007) (Cth)
COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUBSECTION 85(2)
No. PB 2 of 2007
I, JOAN CORBETT, 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 January 2007.
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 is, in this Declaration, referred to as the Principal Declaration.
Schedule 1 to the Principal Declaration is amended:
(a) in respect of the pharmaceutical benefit Ezetimibe, 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 in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease whose cholesterol levels are inadequately controlled with a statin, and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with diabetes mellitus whose cholesterol levels are inadequately controlled with a statin, and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with peripheral vascular disease whose cholesterol levels are inadequately controlled with a statin, and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with heterozygous familial hypercholesterolaemia whose cholesterol levels are inadequately controlled with a statin, and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with symptomatic cerebrovascular disease whose cholesterol levels are inadequately controlled with a statin, and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Continuing treatment, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease or diabetes mellitus or peripheral vascular disease or heterozygous familial hypercholesterolaemia or symptomatic cerebrovascular disease whose cholesterol levels were inadequately controlled with a statin, where the patient has previously been issued with an authority prescription for this drug
For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is contraindicated
For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is unsuitable because the patient developed a clinically important product-related adverse event during treatment with a statin and required discontinuation of all statin treatment, and where a clinically important product-related adverse event is defined as follows:
Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin
Homozygous sitosterolaemia
For use in accordance with paragraph 16, in combination with an HMG CoA reductase inhibitor (statin), in patients with homozygous familial hypercholesterolaemia
(b) in respect of the pharmaceutical benefit Ezetimibe with Simvastatin, 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, in conjunction with dietary therapy and exercise, of patients with coronary heart disease whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Initial treatment, in conjunction with dietary therapy and exercise, of patients with diabetes mellitus whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Initial treatment, in conjunction with dietary therapy and exercise, of patients with peripheral vascular disease whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Initial treatment, in conjunction with dietary therapy and exercise, of patients with heterozygous familial hypercholesterolaemia whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Initial treatment, in conjunction with dietary therapy and exercise, of patients with symptomatic cerebrovascular disease whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:
(a) inadequate control with a statin is defined as:
(i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or
(ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and
(b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and
(c) the cholesterol level results provided are no more than 2 months old at the time of application
Continuing treatment of patients with coronary heart disease or diabetes mellitus or peripheral vascular disease or heterozygous familial hypercholesterolaemia or symptomatic cerebrovascular disease whose cholesterol levels were inadequately controlled with an HMG CoA reductase inhibitor (statin), where the patient has previously been issued with an authority prescription for ezetimibe with simvastatin or for ezetimibe used concurrently with 40 mg or greater of a statin
For use in accordance with paragraph 16 in patients with homozygous familial hypercholesterolaemia
(c) in respect of the pharmaceutical benefit Glucose Indicator—Blood, by inserting in column 2 “electrode strips, 50 (MWD Pen Sensor Strips),” after “electrode strips, 50 (GlucoMen Sensor),” and inserting “electrode strips, 50 (Omnitest Plus),” after “electrode strips, 50 (Omnitest EZ),”;
(d) by omitting the details in respect of the pharmaceutical benefit Moxifloxacin Hydrochloride.
Dated this 1st day of December 2006.
JOAN CORBETT
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
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