Wider prescribing of Amgen’s PCSK9 inhibitor to improve health equity in high risk cardiovascular disease

Pharma News: Effective 1 December 2022, the Pharmaceutical Benefits Scheme (PBS) listing for Amgen’s PCSK9 inhibitor will be expanded and barriers to initiation of therapy will be removed in the treatment symptomatic atherosclerotic cardiovascular disease (CVD).

The expanded PBS listing of Repatha (evolocumab) – to low density lipoprotein cholesterol (LDL-C) of >1.8 millimoles per litre (from previous threshold of >2.6mm/L) – will provide an additional treatment option for up to 12,000 more Australians at high risk of a recurrent heart attack or stroke. Critically, this lowering of the LDL-C threshold aligns with the Australian clinical guidelines for high-risk CVD patients and is a step toward European guidelines, which recommend LDL-C levels of below 1.4 millimoles per litre for those at very high risk.

Professor Stephen Nicholls, Director of the Victorian Heart Institute and President of the Cardiac Society of Australia and New Zealand, said “We know that persistent high levels of LDL-C continue to drive a high rate of heart attack and stroke in this country. Unfortunately, for a whole lot of reasons, many patients are unable to lower their LDL-C to the levels needed to reduce their risk of a serious cardiovascular event.”

Every day, 110 Australians have a heart attack and 79 experience a stroke. Unfortunately, after leaving hospital, a large proportion of these people don’t take the recommended medications that would reduce their risk of a second CV event. Additionally, 40% of people who have already experienced a CV event are still unable to reach recommended LDL-C targets when treated with traditional therapy.

Repatha’s expanded PBS listing now also allows for General Practitioners (GPs) to prescribe the treatment in consultation with a specialist, without needing to refer patients on. This is significant in improving equity of access for First Nations people, those living in regional and remote communities, older Australians, and people from lower socio-economic backgrounds.

“GPs are such an important part of a patient’s care team. This change gives GPs more to work with to play their important role in the management of CVD patients and will also help patients to access treatment sooner, and hopefully continue with treatment in the long-term,” Professor Nicholls said.

CVD remains the single greatest cause of death in Australia, claiming around 40,000 lives every year.

Repatha is the only PCSK9i to date to show long-term clinical outcomes in patients with atherosclerotic cardiovascular disease. The Phase 3 FOURIER open label extension study, with median follow up of 5 years, was presented at the European Society of Cardiology (ESC) congress 2022 and revealed a 15% lower risk of cardiovascular death, myocardial infarction and stroke (p=0.008), 20% lower risk of cardiovascular death, myocardial infarction or stroke (p=0.003), and 23% lower risk of cardiovascular death (p=0.04).

Tanya Hall, CEO of hearts4heart, noted “Living with CVD can be incredibly taxing on not only the individual, but on their family and those who care for them. Many are so sick they are unable to work, live a life of limitations and in constant fear of another heart attack or stroke. This reduced quality of life can have a huge impact on their mental and emotional health and on those who care for them.”

Dr Cae Tolman, Country Medical Director, Amgen Australia & New Zealand, said “Amgen is proud to be playing our part to support Australians living with high-risk CVD. We are pleased that more Australians living with CVD now have access to an additional treatment option.”

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