GENERAL STATEMENT FOR LIPID-LOWERING DRUGS PRESCRIBED AS PHARMACEUTICAL BENEFITS

GENERAL STATEMENT FOR LIPID-LOWERING DRUGS PRESCRIBED AS PHARMACEUTICAL BENEFITS

Use the following criteria to determine patient eligibility for subsidisation under the PBS for the following drugs:

  • atorvastatin calcium
  • fluvastatin sodium
  • pravastatin sodium
  • rosuvastatin calcium
  • simvastatin
  • fenofibrate
  • gemfibrozil

By writing a PBS prescription, the prescriber is certifying the patient satisfies the qualifying criteria set out below and the use is in accordance with the registered indications which differ between agents in this class - refer to the current Product Information for details. Note also that patients already established on a particular lipid-lowering drug, where use satisfies the PBS qualifying criteria, but is outside the registered indications for that drug, are not required to switch to another drug in the class to retain PBS eligibility.

Patients in very high risk categories (see below) may commence drug therapy with statins or fibrates immediately (ie simultaneously with an appropriate diet). For all other patients, dietary therapy should be trialled prior to initiation of drug therapy.

Dietary therapy should be continued concurrently with pharmacological therapy and should be reviewed on at least an annual basis.

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

If your patient is not identified as being in any of the above very high risk categories, then use the flow-chart and table below to determine whether your patient satisfies the following criteria for subsidisation under the PBS. Document how the patient meets each of these steps in the patient record. Lipid levels must be measured at an accredited laboratory.

 

 

General Statement for Lipid-Lowering Drugs

POST-DIETARY QUALIFYING CRITERIA 

Dietary therapy should be continued concurrently with pharmacological therapy and should be reviewed on at least an annual basis.

PATIENT CATEGORY   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