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PBS change allows GPs to prescribe evolocumab

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The Pharmaceutical Benefits Scheme (PBS) listing for evolocumab (sold as Repatha) has been expanded, in a move that will allow GPs to prescribe the medication and also lower the eligibility threshold for patients who qualify for the treatment.
 
Under the new criteria, GPs will be able to initiate evolocumab in consultation with a specialist, while it is also now indicated for patients with low-density lipoprotein cholesterol (LDL-C) greater than 1.8 mmol/L per litre in the presence of symptomatic atherosclerotic cardiovascular disease (CVD) – a significant lowering of the previous threshold of more than 2.6 mmol/L.
 
The new LDL-C threshold will also apply to the listing for familial hypercholesterolaemia patients, where the >2.6 mmol/L threshold previously applied.
 
RACGP Rural Chair Associate Professor Michael Clements told newsGP he is ‘very supportive’ of the decision, which provides an additional treatment option for Australians at high risk of heart attack or stroke, and also improves access to the drug in regional areas, where people are 60% more likely to die from  CVD and often have limited access to specialists
 
‘I’m very pleased to see this and am genuinely hoping that this is the start of, or at least continues, the recognition of the role that GPs have in prescribing previously “specialist-only” medications,’ he said.
 
‘Because the reality is, just as was identified with Repatha, many rural and remote patients will actually just do without the medication rather than have to go through the process of a non-GP specialist referral.
 
‘I have patients who would benefit from this medication – but when you’re in a remote clinic and you advise them that it’s going to take several months … to just get a new tablet that might lower their cholesterol and reduce their cardiovascular risk just a little bit more, you can see that that’s a huge barrier towards many people getting what they’re quite rightly entitled to.’
 
Evolocumab is a biologic medicine that targets and blocks the PCSK9 protein to assist with lowering the amount of LDL-C in the blood and clearing it from the liver. It is administered by subcutaneous injection with a dose of 140 mg every two weeks or 420 mg every month.
 
On average, 110 people per day in Australia have a heart attack and 79 experience a stroke. However, a large proportion of these people do not take the recommended medications that would reduce their risk of a secondary cardiovascular event after leaving hospital – which is where GPs come in.
 
Research shows that people who have contact with community-based healthcare services and see their local doctor regularly are more likely to continue to take their recommended medication, and RACGP Victoria Chair Dr Anita Muñoz says GPs have an ‘important role’ to play in managing these patients.
 
‘The majority of patients we see who are high-risk are really challenged in being able to achieve the recommended LDL-C targets, putting them at grave risk of serious cardiovascular events,’ she said.
 
‘Being able to prescribe another option that may help to reach these targets will offer a great opportunity to manage the disease in high-risk patients, giving them more options earlier in their treatment journey.’
 
The expanded PBS listing was based on the randomised, double-blind placebo-controlled FOURIER trial, in which patients treated with evolocumab, in addition to statin therapy (with or without ezetimibe), significantly reduced their risk of cardiovascular events compared to patients who received the placebo.
 
In particular, recipients showed a:
 

• 59% reduction in LDL-C compared with patients who only received background lipid-lowering therapy
• 15% reduction in the risk of cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina, or coronary revascularisation compared to placebo
• 50% or greater reduction in LDL-C at the mean of weeks 10 and 12 in 80–85% of all patients with either dose.

 
Associate Professor Clements says PBS restrictions are typically in place for medications with side effects that may need to be managed by a non-GP specialist, or when cost–benefit analyses indicate that wider access is not financially sustainable for government.
 
But he believes many of these barriers actually increasing Medicare costs.
 
‘You’re making us do a referral to a specialist, they’re going to charge Medicare as well, and you’re delaying time to treatment,’ he said.
 
‘To me, it’s clear that we really do need to look at the raft of medications that are out there that are so called “specialist only” and consider other opportunities – such as ADHD medications and Roaccutane.’
 
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cardiovascular disease evolocumab PBS prescribing Repatha

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