Lipid Management & FH (familial hypercholesterolaemia)
Supporting primary care to optimise lipid management pathways.
Overview
Building on the three-year lipid management programme to improve outcomes in patients with cardiovascular disease and familial hypercholesterolaemia (FH)
Supporting and working with health and care professionals to increase confidence, knowledge and adherence to the lipid lowering pathways as part of the lipid service re-design taking place in the region
Detailed Programme Information
A key element of the NHS Long Term Plan is reducing the incidence of Cardiovascular Disease (CVD), which causes a quarter of all deaths in the UK, particularly in deprived areas.
Lipid Management
Over the next 12 months the South West AHSN is aiming to ensure that more patients ‘at risk’ of and with CVD are affectively treated for their cholesterol. Our support involves increasing awareness and knowledge of the national guidance for lipid management and it’s associated pathways in both primary and secondary care. We are working collaboratively with our partners to deliver targeted education across the region to re-design and deliver improved lipid services and share best practice across the region.
The AHSN Network Lipid Management and Familial Hypercholesterolaemia programme has a focus on optimising the treatment of disordered lipids to give patients the best chance of avoiding cardiac events.
This page has been created to provide information to healthcare professionals about the treatment options for disordered lipids, as outlined in the Lipid Management Pathway.
Why is Lipid Management a priority?
Cardiovascular disease (CVD) is associated with brain, heart and vascular health risks and makes up the leading cause of death in England 2
- 137,000 deaths per year of which 37,000 (26%) are premature2
- 6.8 million living with CVD2
- £7.4bn in costs to the NHS, and £15.8bn with the wider economy2
Preventing and managing CVD and its risk factors has the potential to improve population health and ease pressures on overstretched health and care systems by reducing demand for services.
Lipid management in England must improve to drive better CVD outcomes
- Every 1 mmol/L reduction in LDL-C is tied to a 22% reduction in major vascular events after 1 year3
- A EU-wide study revealed that 61% of high-risk ASCVD patients are unable to reach an LDL-C goal of <1.8mmol (ESC target) signposting the need for a different approach4
Lipid control is a vital part of this: 43% of all adults live with LDL-C levels above national guidelines2
LDL-C management for secondary prevention is a clinical priority for patients and the NHS, as recognised by incentives in the 2023/2024 QOF amounting to 30 points and ~£36 million in funds 1.
The 2023/2024 updates of QOF include a non-HDL target that is lower than 2.5 mmol/L or where non-HDL cholesterol is not recorded an LDL-C target of lower than 1.8 mmol/L for secondary prevention patients. 1
The 1.8 mmol/L LDL-C target in the QOF may not be reachable for some patients with statins alone.4
Many high-risk CVD patients could still benefit from further treatment optimisation and access to further combination therapies within the lipid management pathway
Despite other successful lipid management initiatives by the AAC and AHSNs in England, many high-risk CVD patients could still benefit from further treatment optimisation and access to further combination therapies.
Statins
Statins are a class of lipid-lowering medications that reduce cholesterol levels in those who are at high risk of Cardiovascular Disease. They are the most common cholesterol-lowering drugs.
Large clinical research studies, involving many thousands of people, have shown that lowering bad cholesterol reduces your risk of heart disease – especially heart attacks.
Prescribing statins
There are several statins available in the UK. They all work in the same way, but have slightly different chemical structures. Statin choice and dose will be made depending on medical history and target cholesterol level. Most statins are taken at night, because more cholesterol is produced whilst people sleep, although some statins can be taken at any time of the day.
Ezetimibe
Ezetimibe is a “cholesterol absorption inhibitor” which works by partially blocking the absorption of cholesterol in the small intestine. This means less cholesterol enters your blood from food and bile so the liver has to take more cholesterol out of the blood to make more bile, which is needed for digestion.
The liver does this by increasing the number of low-density lipoprotein (LDL) receptors on your liver cells. These receptors catch LDL cholesterol as it passes by and removes it from the blood.
Prescribing Ezetimibe
Ezetimibe 10mg tablet taken once daily. It might be combined with a statin or taken on its own if a patient is unable to take statins.
Taking ezetimibe with a statin
Ezetimibe works well in combination with a High Intensity Statin (HIST), such as Atorvastatin or Rosuvastatin, when statins alone are not reducing cholesterol levels down to target on their own, including for rare conditions such as homozygous FH and sitosterolaemia.
Taking ezetimibe only
Ezetimibe is licensed to be used on its own if a patient has primary hypercholesterolaemia, which includes heterozygous FH as well as other conditions, and is unable to take statins or they are not working.
Ezetimibe is not suitable during pregnancy or if someone is breastfeeding.
More information
Ezetimibe 10 mg tablets – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)
Overview | Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia | Guidance | NICE
Bempedoic Acid
Bempedoic acid is a new treatment option for people with high cholesterol. It can be used when statins are not suitable, and ezetimibe is not working well enough on its own.
Like statins, bempedoic acid lowers cholesterol in the blood by reducing the production of cholesterol in the liver. Statins block an enzyme known as HMG-CoA reductase. Bempedoic acid works in a similar way, by slowing down a different enzyme in the cholesterol production pathway known as ATP citrate lyase – but only in the liver. This means there are more low-density lipoprotein (LDL) receptors in the liver, which helps to remove more LDL cholesterol from the blood.
Unlike statins, bempedoic acid only works in the liver so it is much less likely to cause side effects in the muscles – one of the main reasons some people do not take statins.
Prescribing Bempedoic Acid
Bempedoic acid 180 mg once daily is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- In combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-c goals with the maximum tolerated dose of a statin, or,
- Alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.
More information
Overview | Bempedoic acid with ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia | Guidance | NICE
Nilemdo 180mg film-coated tablets – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)
Inclisiran
Inclisiran is a first-in-class small interfering RNA therapy which received a licence from the European Commission in December 2020 following the results of a robust clinical development programme. The drug also gained NICE approval on 1 September 2021, recommending the drug for people with high cholesterol who have already had a previous cardiovascular event to reduce their LDL (low-density lipoproteins) cholesterol, which is a key risk factor for them having a subsequent event.
The drug removes harmful LDL cholesterol (LDL-c) from the blood and in three studies across over 3,700 patients is proven to reduce LDL-c by 50% by using RNA interference (RNAi) to boost the liver’s ability to remove it from the blood.
Prescribing Inclisiran
Inclisiran is an LDL-c lowering therapy that, with two maintenance doses a year (following an initial dose and a follow-up dose at 3 months), delivers effective and sustained LDL-c reduction.
Inclisiran is indicated in adults for secondary prevention with primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet:
- In combination with a statin or statin with other lipid lowering therapies, in patients unable to reach LDL-c goals with the maximum tolerated dose or a statin, or
- Alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.
The AHSN Network is the delivery partner for the deployment of Inclisiran in England, working in partnership with NHS England. As a Network, AHSNs (Academic Health Science Networks) are working closely with clinicians across the country to support the healthcare system in the introduction of Inclisiran into local lipid management pathway. Inclisiran is one of the treatment options available as part of the pathway, with a goal to better manage patient cholesterol and lead to better outcomes for our population.
PCSK9 inhibitor
PCSK9i is a lipid lowering therapy (LLT) only prescribed to patients who have previously taken other forms of LLT (including high intensity statins and ezetimibe), however their cholesterol levels still remain above recommended levels. It can also be administered to people who cannot tolerate statins.
Prescribing PCSK9i
It is a self administered injection every 2 to 4 weeks and works differently to statins by reducing the amount of PCSK9 protein in the body, produced by the liver. In reducing the amount of PCSK9 protein, the inhibitors allow the body to remove cholesterol more effectively.
PCSK9i is much more expensive than a statin, however, cost savings are made against the number of heart attacks and strokes prevented.
As it is classed as a ‘red drug’, it can only be prescribed by a specialist in secondary care.
Familial Hypercholesterolaemia detection
We are working to improve the identification of patients with, or at risk of, familial hypercholesterolaemia, a genetic disease which results in high blood cholesterol and an increased risk of early cardiovascular disease (CVD). This involves:
- Working to increase the numbers of patients who have their cholesterol measured.
- Screening electronic records to identify those who meet the clinical diagnosis of FH, and support awareness of the referral pathways for genetic testing
- Piloting child-parent screening.
- Identifying and supporting discussions locally of noval approaches to reduce inequalities in access to FH services.
This will enable early diagnosis and treatment for those at genetic risk of sudden cardiac death.
For more information on FH and the Lipids Pathway, please contact Harriet Matthews, CVD Programme Manager for Tech Enabled Care.
Useful Links
- Webinar: Implementing the latest NICE approved Lipid Management Pathway
- NICE approved clinical pathway
- Summary of National Guidance for Lipid Management for Primary and Secondary Prevention of CVD (NHS England and Accelerated Access Collaborative, July 2021)
- NICE Guidance on Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia (October 2021)
- Statin Intolerance Pathway (NHS England and Accelerated Access Collaborative
- NHS Long Term Plan - reducing cardiovascular disease
- Accelerated Access Collaborative
- Information from the AHSN Network
- A new lipids pathway: its relevance for primary care (Practice Nurse, January 2022)
