What is it?
Improving outcomes for patients with cardiovascular disease (CVD) is a clinical priority in the NHS Long-Term Plan. To support delivery of this part of the NHS Long-Term Plan, the Accelerated Access Collaborative (AAC) Lipid Management Rapid Uptake Product (RUP) Working Group have developed a NICE-endorsed clinical pathway along with a companion document for statin intolerance:
- Summary of national guidance for lipid management for primary and secondary prevention of cardiovascular disease (CVD); and
- Statin intolerance pathway.
The aim of these pathways is to simplify and encourage adherence to national guidance for optimal management of patients at high risk of CVD and reducing the incidence of heart attacks or strokes. This RUP has an exclusive focus on secondary prevention and the AAC is working in partnership with the North East and North Cumbria AHSN, who are leading the AHSN Lipid Management and FH Programme.
There are three classes of medicines in the clinical pathway: high-intensity statins (HISTs); Ezetimibe; and PCSK9 inhibitors. All three lower low-density lipoprotein (LDL) cholesterol.
HISTs help reduce LDL cholesterol – atorvastatin 80mg lowers LDL by approximately 55%.
Ezetimibe can be used either as an adjunct to HISTs or as monotherapy (the use of a single drug to treat a disease or condition) if a patient is intolerant to statins. They may also be used in addition to a PCSK9 inhibitor.
Two medicines, Alirocumab and Evolocumab, belong to a class of medicines known as PCSK9 inhibitors. A PCSK9 inhibitor can be used together with statins in patients who require further lipid lowering or independently in those who are unable to take or tolerate a statin.
To reduce barriers to prescribing, where CCGs adopt a ‘Blueteq prior approval’ form for selected high cost medicines, the AAC has designed a standardised form to secure approval of PCSK9 inhibitors. The form incorporates the information required in accordance with NICE guidance TA393 and TA394.
What are the benefits?
- Reduced risk of admissions and re-admissions associated with CVD.
- HISTs and Ezetimibe are both generic medicines available in primary and secondary care.
- In clinical trials PCSK9 inhibitors have been shown to reduce LDL by approximately 60% and maximum reduction within 4 weeks.
- Large scale outcomes trials have also shown PCSK9 inhibitors to lower the risk of heart attack and stroke.
- PCSK9 inhibitors provide an additional treatment option to statins and ezetimibe in high-risk patients who previously remained at risk despite receiving the maximum dose of those medicines that the individual could tolerate.
- PCSK9 inhibitors can be self-administered by patients with free homecare service available.
- Follow the links to discover more about the PCSK9 inhibitors pathway transformation at Leeds Teaching Hospitals NHS Trust through NICE shared learning:
- Discover more about the PCSK9 inhibitors pathway transformation at Royal Brompton and Harefield NHS Foundation Trust through NICE shared learning.
- NICE Pathways: Cardiovascular Disease Prevention
- HEART UK: PCSK9 inhibitor.