Applications

1512 – Apolipoprotein B testing for high risk cardiovascular disease risk assessment

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Not supported

Application details

Reason for application

New MBS item

Service or technology in this application

ApoB is an essential and functional component of liver- derived very-low density lipoprotein (VLDL) and its metabolic remnants, intermediate density lipoprotein (IDL), LDL, as well as lipoprotein(a) [Lp(a)]. Plasma concentrations of apoB reflect the total number of atherogenic particles present in the circulation because each of these contains one molecule of apoB. Like LDL-cholesterol, an increased plasma concentration of apoB has been shown to be a key risk factor for the development of atherosclerotic CVD.

In a series of prospective epidemiological studies, plasma apoB (a measure of the number of VLDL, IDL, LDL, and Lp(a) particles), as measured by immunoassay, has been shown to be superior to LDL-cholesterol (a measure of the mass of cholesterol within LDL, IDL and Lp(a) particles) and non-HDL-cholesterol (a measure of the mass of cholesterol within VLDL, IDL, LDL, and Lp(a) particles) as markers of cardiovascular risk.

Type: Investigative

Medical condition this application addresses

Cardiovascular disease (CVD) is largely preventable and the evaluation of risk through a comprehensive clinical and diagnostic assessment of the patient allows for more effective management of modifiable risk factors. Individual risk factors such as high blood pressure and raised lipid levels are known to be associated with increased risk of CVD events.

Measurement of apolipoprotein B (apoB) may be most relevant in patients who are hypertriglyceridaemic owing to mixed hyperlipidaemia or as an isolated abnormality. This encompasses patients with metabolic syndrome, obesity, type 2 diabetes, chronic kidney disease, and familial hyperapobetalipoproteinaemia (hyperapoB). It is also helpful in diagnosing genetic hypocholesterolaemic lipid disorders, including familial hypobetalipoproteinaemia and abetalipoproteinaemia, where apoB levels are very low or absent.

ApoB together with cholesterol and triglyceride can be used to define hyperapoB, a heterogeneous condition associated with small dense LDL and a high risk of atherosclerotic CVD.

Application documents

Application form

Consultation survey

Public summary document

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Meetings to consider this application

  • PASC meeting: 12 - 13 April 2018
  • ESC meeting: 10 - 11 October 2019
  • MSAC meeting: 28 - 29 November 2019