NICE has rubber-stamped the approval of a new drug for GP patients at high cardiovascular risk because of raised triglyceride levels.
Icosapent ethyl could now be prescribed by GPs in around 425,000 people in England and Wales after the final technology appraisal was published yesterday.
The oral drug is recommended for adults with a high risk of cardiovascular events and raised fasting triglycerides (1.7 mmol/litre or above) who are taking statins.
However, they must also have established cardiovascular disease, such as a previous stroke, heart attack or a diagnosis of unstable angina, and LDL-cholesterol levels above 1.04 mmol/litre or lower than or equal to 2.60 mmol/litre.
In making the decision, the committee said there were no other treatment options to reduce the risk of cardiovascular events in people taking statins who have controlled levels of LDL-C but raised levels of triglycerides.
It comes after clinical trials showed icosapent ethyl reduced the risk of cardiovascular events in this group compared with placebo.
A double-blind randomised phase three clinical trial of more than 8,000 patients over an average of 4.9 years showed a 25% relative reduction in the risk of future major adverse cardiovascular events.
The new treatment will be given as two tablets taken twice daily. It costs £144.21 per pack of 120 capsules, although NICE noted that local procurement deals may apply.
While the cost-effectiveness of the treatment is uncertain, it is unlikely to be cost-effective for primary prevention, NICE said.
To be eligible for the drug, patients must be taking a statin.
The mechanism of action of icosapent ethyl is not fully understood, NICE noted, and in addition to reducing triglyceride levels, it may also have localised anti-inflammatory effects, regulation of lipid metabolism gene transcription, antithrombotic effects and plaque reduction.
When publishing the draft guidance last month, NICE said it had worked closely with the drug manufacturer Amarin, to ‘identify the population most likely to gain the greatest benefit from icosapent ethyl, striking a balance between effectiveness and the best use of public funding’.
Last month, an international panel of experts concluded that additional cholesterol-lowering drugs should be offered to those with a high cardiovascular risk already on a statin.
NICE recommendation for icosapent ethyl
Icosapent ethyl is recommended as an option for reducing the risk of cardiovascular events in adults. It is recommended if they have a high risk of cardiovascular events and raised fasting triglycerides (1.7 mmol/litre or above) and are taking statins, but only if they have:
- established cardiovascular disease (secondary prevention), defined as a history of any of the following:
- acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation)
- coronary or other arterial revascularisation procedures
- coronary heart disease
- ischaemic stroke
- peripheral arterial disease, and
- low-density lipoprotein cholesterol (LDL‑C) levels above 1.04 mmol/litre and below or equal to 2.60 mmol/litre.
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