PCSK9 Inhibitors

What is it?

Two medicines, alirocumab and evolocumab, belong to a class of medicines known as PCSK9 inhibitors.

They increase the options available to treat high cholesterol levels and reduce the risk of cardiovascular disease (CVD), including heart attack or stroke, in patients with the genetic disease Familial Hypercholesterolaemia, or those who have had a previous CVD event.

A PCSK9 inhibitor can be used together with statins or independently in those who are unable to take or tolerate a statin.

What are the benefits?

  • In some clinical trials, PCSK9 inhibitors have lowered LDL cholesterol levels by more than half compared to placebo.
  • Large scale outcomes trials have also shown PCSK9 inhibitors, in addition to maximum tolerated statin therapy to lower the risk of heart attack and stroke.
  • Reduced risk of admissions and re-admissions associated with cardiovascular disease.
  • Provide an additional treatment option in high-risk patients who previously remained at risk despite maximum tolerated statin therapy.
  • Self-administered by patients with free homecare service available.

Where to start?

The AAC has supported the development of a Lipid Management Algorithm for Primary and Secondary Prevention of Cardiovascular Disease and a companion document dealing with statin intolerance. These were created in partnership with the PCSK9 clinical working group to simplify and encourage adherence to national guidance for optimal management of patients with hypercholesterolaemia and both have been reviewed and endorsed by NICE. The summary guidance can be found here:

For those CCGs that choose to adopt the ‘Blueteq prior approval’ process for prior approval of selected high cost medicines, the AAC partners have designed and recommend this standardised form for use for PCSK9 inhibitors. The form incorporates the information required in accordance with NICE guidance TA393 and TA394.

Further information

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