News

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New PBS listing for high-risk CVD patients

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GPs can now prescribe subsidised icosapent ethyl (sold as Vazkepa) to patients at high risk of cardiovascular disease (CVD), thanks to its new listing on the Pharmaceutical Benefits Scheme (PBS).
 
The listing makes it the first reimbursed medication targeting elevated triglycerides to reduce the risk of further major events for high cardiovascular risk patients.
 
Icosapent ethyl is the only purified eicosapentaenoic acid-based omega-3 fatty acid approved by the Therapeutic Goods Administration (TGA).
 
GP and researcher Professor Ralph Audehm welcomed the addition, describing it as ‘another tool in GPs’ toolbox’.
 
‘Anything that reduces that residual risk in our high-risk patients is important and it’s worthwhile,’ he told newsGP.
 
‘This is an ever-evolving field and it’s great that we’re chipping away at that residual risk because essentially, quite substantially if you look at all the trials, despite optimal therapy, people still go on to have further heart attacks.

‘If you think of someone who’s got diabetes or has heart disease, you’ve got them on statins, their LDL is at target, but their triglycerides are still elevated, and we know they’re at high risk … this just reduces that risk of further events down the line.’
 
The Pharmaceutical Benefits Advisory Committee (PBAC) originally knocked back the listing, saying there was ‘low clinical need for icosapent ethyl given current therapies’ and that it would ‘complicate the treatment space at a substantial potential cost to Government’.
 
However, it was resubmitted for consideration in March this year, and ultimately recommended, before going live on the PBS on 1 October.
 
‘The PBAC was satisfied that icosapent ethyl provides, for some patients, a significant improvement in efficacy over standard care of care (consisting of dietary modification, lifestyle interventions, and concomitant optimisation of low-density lipoprotein cholesterol lowering using a statin-based therapeutic regimen),’ it said.
 
The PBAC lists several criteria to be met before the treatment is prescribed, where the patient must:

• use it in combination with dietary therapy and exercise
• have at least one of coronary artery disease, cerebrovascular or carotid disease, or peripheral arterial disease
• 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, have developed clinically important product-related adverse events necessitating withdrawal of statin treatment, or be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information
• have an LDL cholesterol level between 1.0 mmol/L and 2.6 mmol/L
• have a fasting triglyceride level between 1.7 mmol/L and 5.6 mmol/L.

Professor Gary Jennings is Chief Medical Officer at the Heart Foundation and said one of the key reasons people have preventable second or third cardiac events is that there is often a gap between being discharged from hospital and seeing a GP.
 
Professor Jennings said that, particularly with the cost-of-living crisis, the cost of medication and medical treatment can be one barrier to people getting the most appropriate care.
 
‘We like anything that’s evidence-based and has a good cost–benefit ratio to be available, and that’s the kind of principle that the PBS works with, so we’re very gratified that this and a number of other medications have come on the market,’ he told newsGP.
 
‘But reducing the rate of CVD going forward is not just a matter of better medications, it’s largely going to be a matter of prevention, and we know that to a large extent, the major cardiovascular diseases are preventable.
 
‘We also need to make sure that people don’t go off their medications and do get the best long-term treatment, which can be delivered best by primary care.’
 
The listing comes as CVD continues to have a significant impact on Australia’s healthcare landscape, accounting for one quarter of all deaths and more than 1500 hospitalisations per day. 
 
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cardiovascular disease CVD heart disease LDL PBS statins

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