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PBS-Eligibility Criteria For Lipid Lowering Drugs Fact Sheet

Cholesterol is a major risk factor for the development of cardiovascular disease. The classes of drugs affected by the changes to the PBS eligibility criteria are statins (HMG CoA reductase inhibitors), fibrates and other cholesterol modifying agents.

PDF printable version of PBS-Eligibility Criteria For Lipid Lowering Drugs Fact Sheet (PDF 26 KB)

6 September 2006

Fact Sheet

What are lipid lowering drugs?

These are drugs that lower the level of cholesterol in the blood. Cholesterol is a major risk factor for the development of cardiovascular disease. The classes of drugs affected by the changes to the PBS eligibility criteria are statins (HMG CoA reductase inhibitors), fibrates and other cholesterol modifying agents; for example, atorvastatin, fluvastatin, pravastatin, simvastatin, fenofibrate and gemfibrozil.

Why is PBS-eligibility criteria changing for lipid lowering drugs?

The decision was made following a review of the eligibility criteria by the Pharmaceutical Benefits Advisory Committee.

When do the new criteria come into effect?

Eligibility to lipid lowering drugs will be expanded from 1 October 2006.

Who will qualify for the subsidised drugs?

People with a family history of cardiovascular disease, people with complications of diabetes and patients who already have cardiovascular disease will qualify. Patients should discuss with their doctor if they qualify to receive these drugs on a subsidised basis.

All patients will be expected to maintain good diet in addition to drug therapy and dietary therapy should be reviewed annually.

See page 2 for the full criteria.

Vytorin and Ezetrol are also drugs used to treat high cholesterol. Will Vytorin and Ezetrol be included in the extended listing?

Yes. Vytorin and Ezetrol are not in the statins class of drugs. However, eligibility for Vytorin and Ezetrol is linked to eligibility for statins, and therefore these drugs are covered by the extended eligibility criteria.

What will patients pay for these drugs?

There are many different brands of lipid lowering drugs on the PBS and patients should be able to pay no more than the normal co-payment of $29.50 (general) and $4.70 (concessional).

PBS - eligibility criteria for cholesterol-lowering drugs from 1 October 2006

Patients identified as being in one of the following very high risk categories may commence drug therapy with statins or fibrates at any cholesterol level:

• coronary heart disease which has become symptomatic
• cerebrovascular disease which has become symptomatic
• peripheral vascular disease which has become symptomatic
• diabetes mellitus with microalbuminuria (defined as urinary albumin excretion rate of >20mcg/min or urinary albumin to creatinine ratio of > 2.5 for males, > 3.5 for females)
• diabetes mellitus in Aboriginal or Torres Strait Islander patients
• diabetes mellitus in patients aged 60 years or more
• family history of coronary heart disease which has become symptomatic before the age of 55 years in two or more first degree relatives
• family history of coronary heart disease which has become symptomatic before the age of 45 years in one or more first degree relatives

Other patients are required to meet the lipid levels shown in the following table:

Patients Catergory	Lipid Levels for PBS Subsidy
Patients with diabetes mellitus not otherwise included	total cholesterol > 5.5 mmol/L
Aboriginal or Torres Strait Islander patients Patients with hypertension	total cholesterol > 6.5 mmol/L or total cholesterol > 5.5 mmol/L and HDL cholesterol < 1 mmol/L
Patients with HDL cholesterol < 1 mmol/L	total cholesterol > 6.5 mmol/L
Patients with familial hypercholesterolaemia identified by: DNA mutation; or tendon xanthomas in the patient or their first or second degree relative Patients with: family history of coronary heart disease which has become symptomatic before the age of 60 years in one or more first degree relatives; or family history of coronary heart disease which has become symptomatic before the age of 50 years in one or more second degree relatives	If aged 18 years or less at treatment initiation: LDL cholesterol > 4 mmol/L If aged more than 18 years at treatment initiation: LDL cholesterol > 5 mmol/L or total cholesterol > 6.5 mmol/L or total cholesterol > 5.5 mmol/L and HDL cholesterol < 1 mmol/L
Patients not eligible under the above: men aged 35 to 75 years post-menopausal women aged up to 75 years	total cholesterol > 7.5 mmol/L or triglyceride > 4 mmol/L
Patients not otherwise included	total cholesterol > 9 mmol/L or triglyceride > 8 mmol/L