Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Established atherosclerotic cardiovascular disease with hypertriglyceridaemia

Initial treatment

The treatment must be in conjunction with dietary therapy and exercise; AND

Patient must have at least one of (i) coronary artery disease, (ii) cerebrovascular or carotid disease, (iii) peripheral arterial disease; AND

Patient must be treated with a stable dose of a HMG CoA reductase inhibitor (statin) to achieve target secondary prevention LDL-c levels for at least 12 consecutive weeks; or

Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment; or

Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND

Patient must have LDL cholesterol level between 1.0 millimoles per litre and 2.6 millimoles per litre; or

Patient must have a non-HDL cholesterol between 1.5 millimoles per litre and 3.5 millimoles per litre if LDL cannot be measured/detected; AND

Patient must have fasting triglyceride level between 1.7 millimoles per litre and 5.6 millimoles per litre.

The qualifying fasting triglyceride level and LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, dietary therapy and exercise should be documented in the patient's medical records and must be no more than 8 weeks old.

A clinically important product-related adverse event is defined as follows:

(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or

(ii) 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

(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.

Atherosclerotic cardiovascular disease is defined as:

(i) Documented coronary artery disease (CAD); one or more of the following primary criteria must have been satisfied:

a) Documented multi-vessel CAD (at least 50% stenosis in at least two major epicardial coronary arteries, with or without antecedent revascularisation).

b) Documented prior MI.

c) Hospitalisation for high-risk non-ST-segment elevation acute coronary syndrome, with objective evidence of ischemia: ST-segment deviation or biomarker positivity.

(ii) Documented cerebrovascular or carotid disease; one of the following primary criteria must have been satisfied:

a) Documented prior ischemic stroke.

b) Symptomatic carotid artery disease with at least 50% carotid arterial stenosis.

c) Asymptomatic carotid artery disease with at least 70% carotid arterial stenosis per angiography or duplex ultrasound.

d) History of carotid revascularisation (catheter-based or surgical).

(iii) Documented peripheral arterial disease; one or more of the following primary criteria must have been satisfied:

a) Ankle brachial index (ABI) less than 0.9 with symptoms of intermittent claudication.

b) History of aorto-iliac or peripheral arterial intervention (catheter-based or surgical).

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Established atherosclerotic cardiovascular disease with hypertriglyceridaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be in conjunction with dietary therapy and exercise; AND

The treatment must be co-administered with a HMG CoA reductase inhibitor (statin), unless the patient is contraindicated to statins or has developed statin related adverse events necessitating withdrawal of statin treatment.