NICE has set a threshold for when GPs should escalate lipid-lowering treatment to patients to reduce their cardiovascular disease (CVD) risk.
It is consulting on a proposed a new NICE indicator, due for introduction in December this year, which says treatment should be escalated when non-HDL cholesterol has last been recorded as above 2.6 mmol/litre.
If non-HDL cholesterol is not recorded, GPs should use last recorded LDL cholesterol level and escalate treatment if this is higher than 2.0 mmol/litre.
The update follows an evidence review which has taken place since the last update to CVD guidance, made in May this year, which recommended that statins can now be offered as an option in individuals with a 10-year CVD risk score of less than 10%.
NICE’s guideline committee said it expects that recommending a specific lipid target for secondary prevention of CVD ‘will lead to an increased use of lipid-lowering treatments’, and highlighted that this was in line with NHS England’s recently introduced 2023/24 QOF target.
The committee acknowledged that increased uptake of statins, ezetimibe and other lipid-lowering treatments ‘would result in higher medication and monitoring costs to the NHS’. It also expects it to ‘contribute to increased workload burden in primary care GP practices and pharmacies and in laboratories processing monitoring tests’.
But its guideline committee ‘agreed this increase was necessary for downstream improvements in population health’ and it said the ‘extra cost of lipid-lowering treatment would be partly offset by savings due to a reduction in CVD events (including admissions for stroke or heart disease and cardiovascular procedures)’.
The new indicator, which is for general practice, ‘aims to support improvements in secondary prevention of cardiovascular disease by managing cholesterol levels’ and advises that ‘where non-HDL cholesterol is more than 2.6 mmol/litre (2.0 mmol/litre for LDL cholesterol), treatment should be escalated’ in line with NICE guidance (see box at bottom of article).
Proposed NICE indicator IND2022-133
The percentage of patients with CVD in whom the last recorded non-HDL cholesterol level (measured in the preceding 12 months) is 2.6 mmol/litre or less, or last recorded LDL cholesterol level (measured in the preceding 12 months) is 2.0 mmol/litre or less, if non-HDL cholesterol is not recorded.
Explaining the rationale for the indicator, NICE said that despite the ‘weight of conclusive research and consistent national and international guidelines, many people at significant risk of CVD do not receive lipid-lowering treatments, or they receive inadequate treatment’.
It stated reasons including patient anxiety and reluctance due to perceived risk of side effects but argued that the last five years has brought more evidence on statin side effects; and that that there are now more varied and accurate approaches available to health professionals to make individualised risk assessment.
‘Increasing awareness of elevated lipids (including cholesterol) as a risk factor for CVD, so that appropriate intervention can be provided, is critical to the delivery of the NHS Long Term Plan. By 2029, the ambition in England is for at least 45% of people aged 40 to 74 who are at significant risk of developing CVD to be on appropriate lipid-lowering treatment,’ the consultation document said.
Over 70 million prescriptions for statins are dispensed in England each year, costing the NHS around £100. The total healthcare cost of CVD in England is estimated to be £7.4bn, it highlighted.
Lipid-lowering treatment for secondary prevention of cardiovascular disease
Lipid target for people taking lipid-lowering treatments
1.6.1 For secondary prevention of CVD aim for non-HDL cholesterol levels of 2.6 mmol/litre or less, or where non-HDL is not recorded, LDL cholesterol levels of 2.0 mmol/litre or less. [December 2023]
1.6.2 Offer atorvastatin 80 mg to people with CVD, whatever their cholesterol level. Use a lower dose of atorvastatin if any of the following apply:
- potential drug interactions
- high risk of adverse effects
- patient preference. [May 2023, amended December 2023]
1.6.3 Do not delay statin treatment for secondary prevention of CVD but consider lifestyle changes at the same time if appropriate. [May 2023]
1.6.4 If a person has acute coronary syndrome do not delay statin treatment. Take a lipid sample on admission to hospital and about 3 months after starting treatment. [May 2023]
Optimising treatment for people on statins
1.6.5 If the lipid target for secondary prevention of CVD (see 5 recommendation 1.6.1) is not achieved:
- discuss adherence and timing of statin dose
- optimise adherence to diet and lifestyle measures
- consider increasing the statin dose if started on less than atorvastatin 80 mg and the person is judged to be at higher risk because of 10 comorbidities, risk profile or using clinical judgement. [May 2023, 11 amended December 2023]
1.6.6 If someone reports adverse effects when taking a high-intensity statin try the following strategies with them:
- stopping the statin and trying again when the symptoms have resolved
- changing to a different statin in the same intensity group (rosuvastatin if already receiving atorvastatin)
- reducing the dose within the same intensity group
- changing the statin to a lower intensity group. [2014, amended 19 December 2023]
1.6.7 If a person is not able to tolerate a high-intensity statin aim to treat with the maximum tolerated intensity and dose of statin. [2014, amended December 2023]
1.6.8 Advise the person that any statin at any dose reduces CVD risk. [2014, 24 amended December 2023]
Escalating treatment for people on statins
1.6.9 Offer ezetimibe in addition to the maximum tolerated intensity and dose of statin if the lipid target for secondary prevention of CVD is not achieved (see recommendation 1.6.1). [December 2023]
1.6.10 If the lipid target for secondary prevention of CVD is not achieved (see 1 recommendation 1.6.1), consider alirocumab, evolocumab and inclisiran (see the NICE technology appraisals on inclisiran, evolocumab and alirocumab). [December 2023]
1.6.11 Consider ezetimibe in addition to the maximum tolerated intensity and dose of statin even if the lipid target for secondary prevention of CVD is achieved (see recommendation 1.6.1). [December 2023]
Statins are contraindicated or not tolerated
1.6.12 Offer ezetimibe instead of a statin to people for whom statins are contraindicated or, if after documented discussion of the strategies outlined in recommendation 1.6.6, it is recognised that the person cannot tolerate statins of any intensity or dose. This applies whatever the person’s cholesterol level. [December 2023]
1.6.13 If the lipid target for secondary prevention is not achieved (see recommendation 1.6.1), consider alirocumab, bempedoic acid, evolocumab and inclisiran (see the NICE technology appraisals on inclisiran, bempedoic acid, evolocumab and alirocumab). [December 2023]
Monitoring response to treatment
1.6.14 Measure liver transaminase, total cholesterol, HDL cholesterol and triglyceride levels and calculate non‑HDL cholesterol and LDL cholesterol about 3 months after starting or changing lipid-lowering treatment. [May 2023, amended December 2023]
1.6.15 Provide annual medication reviews for people on lipid-lowering treatment.
- Use these reviews to discuss and encourage medicines adherence and lifestyle changes and address CVD risk factors.
- Consider an annual non‑fasting blood test for non‑HDL cholesterol to 28 inform the discussion. [May 2023, amended December 2023]