A wish list for access to PCSK9 mAbs


By Mardi Chapman

29 May 2019

A review of PCSK9 monoclonal antibodies in Australia has delivered a consensus on the groups of people who would benefit from LDL-cholesterol lowering and a subsequent reduced risk for cardiovascular events.

However to be implemented it would require a costly expansion of PBS indications, according to the expert opinion of 10 cardiologists .

“Broader access for patients in Australia will not only require a marked reduction in price but also a more targeted approach to groups at highest absolute cardiovascular risk,” they wrote in Heart, Lung and Circulation.

The group affirmed that PCSK9 monoclonal antibodies should be considered for the primary prevention of severe hypercholesterolaemias including both homozygous and heterozygous familial hypercholesterolaemia (FH).

Their evidence-based wish list of patients most likely to benefit from secondary prevention with PCSK9 monoclonal antibodies included:

  • peripheral artery disease
  • stroke
  • FH
  • diabetes
  • prior CABG
  • the presence of multivessel coronary disease
  • Aboriginal and Torres Strait Islanders
  • acute coronary syndrome (LDL-C >2.6 mmol/L or >1.8 mmol/L with risk enhancers)
  • very high-risk patients e.g. multiple major ASCVD events or one major event and multiple risk-enhancing conditions.

“Analysis of the efficacy in these subgroups demonstrates superior risk reduction, fewer numbers needed to treat, and ought to lead to a more favourable ICER (incremental cost-effectiveness ratio),” they said.

For example, the FOURIER trial had shown treatment of high-risk patients with diabetes would mean only 37 patients need to be treated to prevent a cardiovascular event/coronary revascularisation over 3 years compared to 63 patients without diabetes.

The reviewers said international guidelines in Europe and the US continue to favour ezetimibe as the first-line non-statin add-on for lipid lowering in all patients.

They also noted that trials of the small interfering RNA inclisiran have shown impressive serum PCSK9 and LDL-C lowering effects.

“If further trials are able to show safety and efficacy when combined with high potency statins it will progress to a cardiovascular outcomes trial and provide significant competition in the PCSK9 inhibition market if they show similar efficacy, particularly given its longer duration of action and lower manufacturing costs,” they concluded.

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