NICE final draft guidance recommends new treatment to prevent heart attacks and strokes in patients with raised blood fats
The National Institute of Health and Care Excellence (NICE) has published final draft guidance recommending icosapent ethyl to reduce the risk of cardiovascular events such as heart attacks and strokes in adults with high levels of triglycerides, a type of blood fat.
This means that approximately 425 000 people may now benefit from the first licensed treatment shown to reduce the risk of heart attacks and strokes in people with controlled low-density lipoprotein cholesterol (LDL-C - also known as ‘bad’ cholesterol) who are taking a statin and have raised triglyceride levels.
Triglycerides are our primary energy source and are necessary for good health. Too much in your blood can indicate an increased risk of cardiovascular events such as heart attacks or strokes. It can also harm arteries in organs like the brain, heart, kidneys and eyes.
Clinical trial evidence has suggested that for patients with raised triglycerides who have LDL-C levels controlled by statins, and who have cardiovascular disease, icosapent ethyl (also called Vazkepa and made by Amarin) reduces their risk of cardiovascular events by over a quarter compared with placebo.
NICE recommends icosapent ethyl for adults with cardiovascular disease who are taking a statin and have controlled LDL-C levels but are still at high risk of cardiovascular events because of raised triglycerides.
According to NHS England, between 25% and 35% of people taking statins have elevated triglycerides. There have previously been no medications for people at risk of cardiovascular events who have elevated triglyceride levels despite taking statins with or without ezetimibe (another type of anti-cholesterol medicine).
Helen Knight, interim director of medicines evaluation at NICE, said: ‘Icosapent ethyl is the first licensed treatment of its kind for people who are at risk of heart attacks and strokes despite well controlled LDL cholesterol because they have raised blood fats. And although lifestyle changes, including diet and exercise, can help to reduce their risk, these may not work for everyone.
‘We have worked closely with the company 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, delivering maximum value to the taxpayer.’
NICE expects to publish its final guidance on icosapent ethyl next month.
NICE recommends Piqray and Trodelvy
An agreement on the price of two breast cancer treatments, with the companies Piqray and Trodelvy, has allowed NICE to make them available immediately to approximately 3450 people on the NHS.
NICE has recommended Piqray (also known as alpelisib and manufactured by Novartis Pharmaceuticals UK) in combination with the hormonal therapy fulvestrant for the treatment of hormone receptor-positive, HER2-negative, PIK3CA-mutated locally advanced or metastatic breast cancer that has grown following treatment with combined hormonal therapy and a cancer growth inhibit
Piqray with fulvestrant, administered as a once-daily tablet, is the first targeted treatment for this type of breast cancer that has grown after treatment with combined hormonal therapy and a cancer growth inhibitor. It works by inhibiting the PI3K enzyme, which, when activated because of a mutation in the PIK3CA gene, causes cancer cells to divide and grow uncontrollably. The goal of blocking this enzyme is to slow the growth and spread of cancer. It is estimated that approximately 2800 people are eligible for Piqray plus fulvestrant treatment.
Trodelvy (also known as sacituzumab govitecan and manufactured by Gilead Sciences) has also been recommended by NICE for treating locally advanced or metastatic triple-negative breast cancer that cannot be removed surgically. It is used after two or more lines of systemic therapy, at least one of which was for locally advanced or metastatic disease that could not be removed surgically.
Trodelvy works by inhibiting the activity of Trop-2 proteins, which are abundant on the surface of tumour cells. By targeting Trop-2, the anti-cancer component of the drug is delivered directly to tumour cells, preventing them from multiplying and eventually killing them.
The clinical trial evidence indicates that Trodelvy increases the time people have before their disease worsens by around 3 months and their life expectancy by about 5 months when compared to chemotherapy. It is estimated that approximately 650 people with advanced triple-negative breast cancer will be eligible for Trodelvy treatment.